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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

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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.Check my eligibility

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.See study design

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 below

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years post-chemotherapy for reporting.

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 more

Other 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