Your session is about to expire
← Back to Search
Alkylating agents
Oral Irinotecan + Temozolomide for Pediatric Solid Cancers
Phase 1
Recruiting
Led By Javier Oesterheld, M.D.
Research Sponsored by Valent Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, as described below: Myelosuppressive chemotherapy: patients must not have received myelosuppressive chemotherapy within 21 days of first study treatment, but nitrosourea within 8 weeks (42 days) of first study treatment Anti-cancer agents not known to be myelosuppressive (e.g., not associated with drops in platelet or neutrophil count): must not have received these therapies within 7 days of first study treatment, or at least 5 half-lives of the agent (whichever is longer) Antibody therapy: At least 4 weeks must have elapsed since last antibody dose prior to first study treatment Radiation therapy: At least two weeks must have elapsed since last local palliative radiation (small port) prior to first study treatment. At least 6 weeks must have elapsed if more substantial radiation was administered (e.g., >50% pelvis, craniospinal, whole body), or therapeutic radiolabeled 131I MIBG or other radiopharmaceutical therapy. High-Dose Chemotherapy with Autologous Stem Cell Transplant/Rescue: At least two months must have elapsed since receiving autologous hematopoietic stem cells prior to first study treatment. Patients who have had allogeneic transplants are ineligible. Hematopoietic growth factors: must not have been received in the 14 days prior to first study treatment for a long-acting growth factor (e.g., pegfilgrastim), or 7 days prior to first study treatment for short-acting growth factor.
Karnofsky Performance Status ≥ 50% for patients > 16 years of age and Lansky Performance Status ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 17 months
Awards & highlights
Study Summary
This trial is testing a flavored, orally-administered form of irinotecan (VAL-413) given with temozolomide to see if it is safe and effective for treating recurrent pediatric solid tumors, including neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma.
Who is the study for?
This trial is for children and young adults aged 1 to 30 with recurrent solid tumors like neuroblastoma or Ewing sarcoma. They must have a certain level of physical ability, no uncontrolled infections, not be pregnant, and agree to use contraception. Participants need normal organ function and can't join if they've had severe allergic reactions to specific drugs or are on certain medications.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a flavored oral form of Irinotecan (VAL-413) combined with Temozolomide in treating pediatric solid tumors. It's designed to see how well patients tolerate this new formulation and measure its impact on their cancer.See study design
What are the potential side effects?
Possible side effects include digestive issues such as diarrhea, nausea, vomiting; lowered blood counts leading to increased infection risk; fatigue; liver problems indicated by altered blood tests; hair loss; and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 16 and can do most activities, or if under 16, I can do many activities without help.
Select...
My kidney function is within the required range for my age and gender.
Select...
I am between 1 and 30 years old.
Select...
My cancer was confirmed by a tissue test at diagnosis or relapse.
Select...
My liver enzyme ALT levels are within 5 times the normal limit.
Select...
My kidney function is within the normal range.
Select...
My cancer was confirmed by a tissue test at diagnosis or relapse.
Select...
My bilirubin levels are within the normal range for my age.
Select...
I haven't taken any cancer drugs that lower blood counts in the last 7 days or 5 half-lives.
Select...
I am between 1 and 30 years old.
Select...
It has been over 4 weeks since my last antibody therapy dose.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 17 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~17 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase II Dose (RP2D)
Secondary outcome measures
AUCinf
AUClast
Adverse Events
+9 moreSide effects data
From 2016 Phase 2 trial • 175 Patients • NCT0105531436%
Febrile neutropenia
31%
Death NOS
30%
Diarrhea
22%
Pain
21%
Hyperglycemia
16%
Anorexia
16%
Infections and infestations - Other, specify
16%
Alanine aminotransferase increased
14%
Hypokalemia
13%
Nausea
11%
Hyponatremia
10%
Weight loss
9%
Aspartate aminotransferase increased
9%
Anemia
9%
Mucositis oral
9%
Vomiting
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
Hypotension
6%
White blood cell decreased
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Anxiety
5%
Typhlitis
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Lymphocyte count decreased
3%
Wound infection
3%
Blood bilirubin increased
3%
Syncope
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Thromboembolic event
2%
Upper gastrointestinal hemorrhage
2%
Vulval infection
2%
Depressed level of consciousness
2%
Stridor
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Esophageal pain
1%
Gastrointestinal disorders - Other, specify
1%
Heart failure
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Vascular disorders - Other, specify
1%
Ascites
1%
Bone marrow hypocellular
1%
Anaphylaxis
1%
Delirium
1%
Sore throat
1%
Vasovagal reaction
1%
Anal hemorrhage
1%
Soft tissue infection
1%
Tracheitis
1%
Anal mucositis
1%
Seizure
1%
Menorrhagia
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)
Trial Design
3Treatment groups
Experimental Treatment
Group I: 90 mg/m2/day VAL-413 (Orotecan®)Experimental Treatment2 Interventions
Orotecan® at 90 mg/m2/day administered with Temozolomide at 100 mg/m2/day orally for 5 consecutive days at the beginning of every 21-day cycle. A single dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO) will be substituted at the same dosage as Orotecan® for during Cycle 1.
Group II: 75 mg/m2/day VAL-413 (Orotecan®)Experimental Treatment2 Interventions
In the event the 90 mg/m2/day starting dose is not tolerable due to toxicity, a lower starting dose of 75 mg/m2/day may be implemented. Orotecan® at 75 mg/m2/day administered with Temozolomide at 100 mg/m2/day orally for 5 consecutive days at the beginning of every 21-day cycle. A single dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO) will be substituted at the same dosage as Orotecan® for during Cycle 1.
Group III: 110 mg/m2/day VAL-413 (Orotecan®)Experimental Treatment2 Interventions
Orotecan® at 110 mg/m2/day administered with Temozolomide at 100 mg/m2/day orally for 5 consecutive days at the beginning of every 21-day cycle. A single dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO) will be substituted at the same dosage as Orotecan® for during Cycle 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
Valent Technologies, Inc.Lead Sponsor
Valent Technologies, LLCLead Sponsor
Javier Oesterheld, M.D.Principal InvestigatorAtrium Health Levine Children's Hospital - Carolinas Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My current cancer treatment options do not include a cure or significantly extend life with good quality.I don't need to have measurable disease to join this study.I am over 16 and can do most activities, or if under 16, I can do many activities without help.My kidney function is within the required range for my age and gender.I am not taking any medication that affects blood clotting, except for acetaminophen.I have not taken strong medication inducers like phenobarbital or St. John's Wort in the last 2 weeks.I am between 1 and 30 years old.My cancer was confirmed by a tissue test at diagnosis or relapse.I've had temozolomide, vincristine, or irinotecan without my cancer getting worse on them.My hemoglobin level is at least 8.0 gm/dL, even if I needed blood transfusions.My liver enzyme ALT levels are within 5 times the normal limit.My kidney function is within the normal range.I don't need to have measurable disease to join this study.My cancer was confirmed by a tissue test at diagnosis or relapse.My bilirubin levels are within the normal range for my age.I haven't taken any cancer drugs that lower blood counts in the last 7 days or 5 half-lives.I've had temozolomide, vincristine, or irinotecan without my cancer getting worse on them.My hemoglobin level is at least 8.0 gm/dL, even if I needed blood transfusions.I have recovered from the side effects of my previous cancer treatments.I am between 1 and 30 years old.It has been over 4 weeks since my last antibody therapy dose.My current cancer treatment options do not include a cure or significantly extend life with good quality.I have not taken strong CYP3A4 or UGT1A1 inhibitors in the last week.I do not have an uncontrolled infection or need IV antibiotics.I can care for myself but may not be able to do active work or play.My platelet count is above 100,000 and I haven't had a transfusion in the last week.I have never had a severe allergic reaction to dacarbazine or certain antibiotics.I agree to use effective birth control during and for 30 days after the study.
Research Study Groups:
This trial has the following groups:- Group 1: 75 mg/m2/day VAL-413 (Orotecan®)
- Group 2: 110 mg/m2/day VAL-413 (Orotecan®)
- Group 3: 90 mg/m2/day VAL-413 (Orotecan®)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings left in this research study for volunteers?
"The information on clinicaltrials.gov reveals that this clinical trial is currently recruiting volunteers for participation. The trial was initially posted on October 25th 2021 and recently updated the 11th of October 2022."
Answered by AI
What have clinical studies revealed about the use of VAL-413 in patient care?
"VAL-413 is a known treatment for nitrosourea, as well as more complex diseases like refractory neuroblastoma, mycosis fungoides and advance directives."
Answered by AI
Is this a pioneering medical experiment?
"Developed by Schering-Plough, the first study for VAL-413 was conducted in 2002 and involved 60 patients. After being approved for Phase 2 trials, 206 studies concerning this drug have been initiated across 36 countries and 935 cities."
Answered by AI
Has VAL-413 been given the green light by the FDA?
"The tentative safety of VAL-413 has been assessed at a score of 1, as this is an early Phase 1 trial with little empirical evidence to support its efficacy and protection."
Answered by AI
Are participants aged 45 or above eligible to join this trial?
"The age requirements for this clinical trial are between 1 Year and 30 Years old. There are 430 studies dedicated to participants under 18, and 996 trials specifically designed for persons over 65 years of age."
Answered by AI
What is the scope of participation in this clinical investigation?
"Affirmative. The records stored on clinicaltrials.gov demonstrate that this trial, which was initially advertised on October 25th 2021 is recruiting individuals at the present time. Specifically, 20 patients need to be enrolled across 2 sites."
Answered by AI
Who qualifies to join this clinical investigation?
"All participants in this clinical trial must have rhabdomyosarcoma and be between the age of one year old and thirty. There is a limit of 20 individuals who may partake in this study."
Answered by AI
Are there any additional experiments that have been conducted on VAL-413?
"Currently, there are 206 VAL-413 clinical trials in live operation, with 23 of the studies having advanced to Phase 3. These clinical trial sites span across 4751 locations globally, with a prominent concentration situated around Seoul and Songpa."
Answered by AI
Who else is applying?
What state do they live in?
Mississippi
How old are they?
18 - 65
What site did they apply to?
Duke University Children's Hospital and Health Center
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger