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Oral Etoposide for Germ Cell Cancer
Phase 2
Recruiting
Led By Nabil Adra, MD
Research Sponsored by Nabil Adra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or serological evidence of non-seminomatous GCT
Age ≥ 18 years at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (i.e. up to 2 years)
Awards & highlights
Study Summary
This trial is testing whether maintenance oral etoposide is better than observation for patients with relapsed GCT who have been treated with HDCT and PBSCT.
Who is the study for?
Adults over 18 with relapsed non-seminomatous germ cell tumors (GCT) who've had high-dose chemotherapy and stem-cell transplant. They must have normal or improving tumor markers, good organ function, no active infections, and not be pregnant or breastfeeding. Participants need to agree to use effective contraception.Check my eligibility
What is being tested?
This phase II trial is testing if taking oral Etoposide after high-dose chemo helps patients with GCT more than just monitoring them without treatment. It's an open label study, meaning everyone knows which treatment they're getting.See study design
What are the potential side effects?
Etoposide can cause low blood counts leading to infection risk, fatigue, nausea, hair loss, mouth sores, diarrhea or constipation. Rarely it may cause allergic reactions or secondary cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of non-seminoma based on tests.
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I am 18 years old or older.
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My cancer returned after first treatment with a cisplatin combo.
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I've completed 2 cycles of high-dose chemotherapy and stem cell transplant as per guidelines.
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I am a woman with an ovarian germ cell tumor.
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My kidney function is normal, with a creatinine level below 2mg/dL.
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I received high-dose chemotherapy as my first follow-up treatment.
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My liver function tests are within the required range.
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I am not able to have children due to age, surgery, or menopause.
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My recent blood tests show my organs are functioning well.
Select...
My last high-dose chemotherapy was within the last 16 weeks.
Select...
My first treatment after my cancer returned was high-dose chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (i.e. up to 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (i.e. up to 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
12-month Progression Free Survival
Secondary outcome measures
12-month Overall Survival
Assess toxicity and tolerability of maintenance etoposide
Side effects data
From 2016 Phase 3 trial • 854 Patients • NCT0000338998%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Maintenance Oral EtoposideExperimental Treatment1 Intervention
Maintenance daily oral Etoposide.
Group II: ObservationActive Control1 Intervention
If randomized to Observation, subjects will jump to follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Find a Location
Who is running the clinical trial?
Nabil AdraLead Sponsor
4 Previous Clinical Trials
127 Total Patients Enrolled
2 Trials studying Germ Cell Tumors
68 Patients Enrolled for Germ Cell Tumors
Nabil Adra, MD5.01 ReviewsPrincipal Investigator - Indiana University
Indiana University
4 Previous Clinical Trials
130 Total Patients Enrolled
1 Trials studying Germ Cell Tumors
50 Patients Enrolled for Germ Cell Tumors
5Patient Review
We had no reservations trusting the referral from my Dad's urologist, Dr. Bihrle, to see Dr. Adra. We were immediately pleased upon meeting him — he's so kind and respectful, not only to my Dad, but to our whole family. He's also an excellent listener, which has meant the world to us during this difficult time. We couldn't ask for more in a doctor, and are confident in his ability to provide the best possible care.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not able to have children due to age, surgery, or menopause.My cancer is a type of non-seminoma based on tests.I am 18 years old or older.My cancer returned after first treatment with a cisplatin combo.I've completed 2 cycles of high-dose chemotherapy and stem cell transplant as per guidelines.I have recovered from previous treatment side effects to a mild level.I am a woman with an ovarian germ cell tumor.My seminoma cancer has come back after treatment.My kidney function is normal, with a creatinine level below 2mg/dL.I agree to use birth control during and for 30 days after the study.I am a woman who can have children and have a negative pregnancy test.I received high-dose chemotherapy as my first follow-up treatment.It's been more than 16 weeks since my last high-dose chemotherapy cycle.My liver function tests are within the required range.My recent blood tests show my organs are functioning well.My recent tests show my organs are working well.I haven't needed treatment for another cancer in the last year.I am currently on medication for an infection.I can care for myself and am up and about more than 50% of my waking hours.My last high-dose chemotherapy was within the last 16 weeks.I am not able to have children due to age, surgery, or hormone levels.My first treatment after my cancer returned was high-dose chemotherapy.I've had 1 or 2 cycles of chemotherapy with specific drug combinations before high-dose chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Maintenance Oral Etoposide
- Group 2: Observation
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.
What maladies does Etoposide typically ameliorate?
"Etoposide is widely employed to treat small cell lung cancer, but has also been shown to mitigate the effects of metastatic thymic cancer, leukemia, myelocytic, acute and advance directives."
Answered by AI
Is the research project currently recruiting participants?
"Affirmative, the information on clinicaltrials.gov shows that this medical trial is still actively enrolling participants. The initial post date was March 3rd 2021 and has been revised most recently on February 23th 2022. This study requires 64 volunteers from one site to complete it's objectives."
Answered by AI
To what extent has Etoposide been explored by other research endeavors?
"Currently, 315 clinical trials are underway studying the use of Etoposide. Of these active studies, 92 have advanced to Phase 3. While most experiments with this drug occur in Houston, Texas there exist 15443 locations conducting research into its efficacy globally."
Answered by AI
What is the sample size of this experiment?
"Affirmative. The information on clinicaltrials.gov indicates that the research project, which was initially shared on March 3rd 2021, is currently recruiting participants. Sixty-four individuals must be acquired from one medical centre for this trial to reach completion."
Answered by AI
Has Etoposide achieved regulatory acceptance from the Federal Drug Administration?
"Based on the assessment conducted by Power, etoposide was rated a 2 because though it has some evidence of safety in trials, there is yet to be any data determining its efficacy."
Answered by AI
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