Temozolomide for Pheochromocytoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pheochromocytoma+5 MoreTemozolomide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how well adding olaparib to temozolomide works in treating patients with neuroendocrine cancer.

Eligible Conditions
  • Pheochromocytoma
  • Metastatic Adrenal Gland Pheochromocytoma
  • Metastatic Paraganglioma
  • Unresectable Adrenal Gland Pheochromocytoma
  • Unresectable Paraganglioma
  • Paraganglioma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: From randomization to the first documentation of disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) or death, assessed up to 5 years

Year 5
Overall survival (OS)
Year 5
Progression-free survival (PFS)
Up to 5 years
Biochemical response
Biomolecular markers associated with clinical outcome
Incidence of adverse events
Objective response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
36%Febrile neutropenia
31%Death NOS
30%Diarrhea
22%Pain
21%Hyperglycemia
16%Alanine aminotransferase increased
16%Anorexia
16%Infections and infestations - Other, specify
14%Hypokalemia
13%Nausea
11%Hyponatremia
10%Weight loss
9%Aspartate aminotransferase increased
9%Constipation
9%Dehydration
9%Hypophosphatemia
9%Vomiting
9%Mucositis oral
9%Anemia
8%Platelet count decreased
8%Sepsis
7%Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%Abdominal pain
7%Colitis
7%Catheter related infection
6%Hypoalbuminemia
6%Hypotension
6%GGT increased
6%Hypocalcemia
6%Fever
6%Urinary retention
6%White blood cell decreased
5%Urinary tract infection
5%Typhlitis
5%Anxiety
5%Neutrophil count decreased
4%Epistaxis
4%Enterocolitis
4%Lipase increased
4%Pleural effusion
4%Urinary tract obstruction
4%Peripheral motor neuropathy
4%Skin infection
4%Serum amylase increased
3%Syncope
3%Dermatitis radiation
3%Bone pain
3%Dyspnea
3%Lymphocyte count decreased
3%Wound infection
3%Hematuria
3%Blood bilirubin increased
3%Edema limbs
3%Hypertension
3%Hypercalcemia
3%Sinus tachycardia
2%Abdominal distension
2%Creatinine increased
2%Lung infection
2%Acute kidney injury
2%Apnea
2%Left ventricular systolic dysfunction
2%Pancreatitis
2%Peripheral sensory neuropathy
2%Rectal hemorrhage
2%Thromboembolic event
2%Stridor
2%Back pain
2%Enterocolitis infectious
2%Hyperkalemia
2%Musculoskeletal and connective tissue disorder - Other, specify
2%Investigations - Other, specify
2%Muscle weakness lower limb
2%Tumor pain
2%Proctitis
2%Pain in extremity
2%Urticaria
2%Depressed level of consciousness
2%Vulval infection
2%Allergic reaction
2%Portal hypertension
2%Upper gastrointestinal hemorrhage
2%Stoma site infection
2%Skin ulceration
1%Hypoxia
1%Multi-organ failure
1%Oral pain
1%Anaphylaxis
1%Ascites
1%Confusion
1%Alkaline phosphatase increased
1%Anal ulcer
1%Ejection fraction decreased
1%Fracture
1%Heart failure
1%Esophageal pain
1%Gastric hemorrhage
1%Gum infection
1%Hepatobiliary disorders - Other, specify
1%Hydrocephalus
1%Ileus
1%Oral hemorrhage
1%Rectal fistula
1%Pulmonary edema
1%Penile pain
1%Sore throat
1%Tracheitis
1%Acidosis
1%Vascular disorders - Other, specify
1%Vasovagal reaction
1%Abdominal infection
1%Anal hemorrhage
1%Bladder spasm
1%Anal mucositis
1%Congenital, familial and genetic disorders - Other, specify
1%Chest wall pain
1%Device related infection
1%Hoarseness
1%CPK increased
1%Depression
1%Gastrointestinal disorders - Other, specify
1%Esophagitis
1%Gastric ulcer
1%Laryngeal mucositis
1%Hypoglycemia
1%Myositis
1%Menorrhagia
1%Nail infection
1%Renal and urinary disorders - Other, specify
1%Pharyngitis
1%Pneumonitis
1%Spinal fracture
1%Seizure
1%Small intestine infection
1%Gait disturbance
1%Encephalopathy
1%Generalized muscle weakness
1%Pelvic pain
1%Laryngeal edema
1%Rectal pain
1%Disseminated intravascular coagulation
1%Endocrine disorders - Other, specify
1%Respiratory, thoracic and mediastinal disorders - Other, specify
1%Pleuritic pain
1%Sinusitis
1%Bone marrow hypocellular
1%Appendicitis
1%Esophageal infection
1%Delirium
1%Ear and labyrinth disorders - Other, specify
1%Esophageal stenosis
1%Hypertriglyceridemia
1%INR increased
1%Myelodysplastic syndrome
1%Rash maculo-papular
1%Respiratory failure
1%Anal fistula
1%Lethargy
1%Fall
1%Dizziness
1%Eye disorders - Other, specify
1%Tooth infection
1%Fatigue
1%Headache
1%Skin and subcutaneous tissue disorders - Other, specify
1%Hypernatremia
1%Insomnia
1%Kyphosis
1%Soft tissue infection
1%Hypomagnesemia
1%Irregular menstruation
1%Irritability
1%Joint range of motion decreased cervical spine
1%Pyramidal tract syndrome
1%Pain of skin
1%Pneumothorax
1%Postoperative hemorrhage
1%Pruritus
1%Salivary duct inflammation
1%Tumor lysis syndrome
1%Upper respiratory infection
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT01055314) in the Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab) ARM group. Side effects include: Febrile neutropenia with 36%, Death NOS with 31%, Diarrhea with 30%, Pain with 22%, Hyperglycemia with 21%.

Trial Design

2 Treatment Groups

Arm II (temozolomide)
1 of 2
Arm I (temozolomide, olaparib)
1 of 2

Active Control

Experimental Treatment

76 Total Participants · 2 Treatment Groups

Primary Treatment: Temozolomide · No Placebo Group · Phase 2

Arm I (temozolomide, olaparib)Experimental Group · 3 Interventions: Olaparib, Quality-of-Life Assessment, Temozolomide · Intervention Types: Drug, Other, Drug
Arm II (temozolomide)ActiveComparator Group · 2 Interventions: Quality-of-Life Assessment, Temozolomide · Intervention Types: Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Temozolomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization to the first documentation of disease progression (per response evaluation criteria in solid tumors [recist] version 1.1) or death, assessed up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,085 Previous Clinical Trials
41,141,387 Total Patients Enrolled
19 Trials studying Pheochromocytoma
1,676 Patients Enrolled for Pheochromocytoma
Jaydira Del RiveroPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must have completed prior treatment with radiolabeled metaiodobenzylguanidine (MIBG) at least 12 weeks ago and have a lifetime cumulative dose of 131I-MIBG of less than 1000 MBq kg-1 (36 mCi kg-1) to be eligible to enroll in this study.
and must include doxycycline You must have been treated with antibiotics for at least seven days prior to registration and must have taken doxycycline.
, or osseous lesions Any lesion measuring >= 1 cm on a computed tomography (CT) or magnetic resonance imaging (MRI) scan is considered measureable
Prior treatment with other chemotherapy, radiotherapy, surgery, PRRT, or other investigational agents must be completed >= 28 days prior to registration
Documentation of disease is present.
A tumor is histologically-proven to be a pheochromocytoma or paraganglioma if it is confirmed to be a tumor of the cells that produce the hormone epinephrine.
You have had radiographic evidence of disease progression by RECIST version (v) 1.1 in the 12 months prior to registration.