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Hormone Therapy
Triptorelin for Cancer
Little Rock, AR
Phase 3
Recruiting
Led By Eric J Chow
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* \< 40 years of age at the time of enrollment
* Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years post-chemotherapy
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial compares giving triptorelin to not giving triptorelin to young people with cancer who are receiving chemotherapy with alkylating agents. Alkylating agents can harm the ovaries
Who is the study for?
This trial is for post-menarchal females under 40 years old, diagnosed with their first cancer (excluding breast cancer), who will receive chemotherapy including alkylating agents. They must have had their first menstrual period over 6 months ago and agree to consent forms. It's not suitable for those who don't meet these criteria or can't follow the study requirements.
What is being tested?
The trial tests if Triptorelin can prevent ovarian damage in young female cancer patients during chemotherapy. Participants are either given Triptorelin or no treatment as a comparison, alongside standard chemo with alkylating agents known to affect ovaries.
What are the potential side effects?
Triptorelin may cause temporary menopause-like effects such as hot flashes, mood changes, and decreased bone density due to its hormone-blocking action. After it leaves the body, normal ovarian function typically resumes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am under 40 years old.
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My treatment plan includes specific chemotherapy drugs aimed at curing my condition.
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My first cancer diagnosis is not breast cancer.
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I am under 20 and my treatment plan includes a high dose of certain chemotherapy drugs, or I am 20 or older and receiving any dose of these drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years post-chemotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years post-chemotherapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Accrual rates of newly diagnosed AYA female cancer patients age < 40 years
Anti-mullerian hormone (AMH) levels
Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years
Secondary study objectives
Estrogen deprivation symptoms: Headaches
Estrogen deprivation symptoms: Hot flashes
Estrogen deprivation symptoms: Sexual function
+9 moreOther study objectives
Reproductive concerns
Reproductive outcomes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (triptorelin)Experimental Treatment4 Interventions
Patients receive triptorelin IM up to 14 days prior to standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.
Group II: Arm B (usual care)Active Control4 Interventions
Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triptorelin Pamoate
2003
Completed Phase 3
~100
Biospecimen Collection
2004
Completed Phase 3
~1810
Find a Location
Closest Location:Arkansas Children's Hospital· Little Rock, AR· 625 miles
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
465 Previous Clinical Trials
240,600 Total Patients Enrolled
Eric J ChowPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
420 Total Patients Enrolled