Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer

Inclusion Criteria:

• < 40 years of age at the time of enrollment

• Patient must be a post-menarchal female and report that their initial menstrualperiod occurred > 6 months prior to enrollment. (Current menstrual status is notpart of the inclusion criteria.)

• Newly diagnosed with first cancer, exclusive of breast cancer.

• Note: Apart from breast carcinoma, other tumor types originating in the breastare permitted (e.g., sarcoma, lymphoma).

• Planned treatment must include one or more of the following alkylating agentsdelivered with curative intent: cyclophosphamide, ifosfamide, procarbazine,chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan,nitrogen mustard.

• For patients < 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m^2 cumulative cyclophosphamide equivalent dose (CED). For patients ≥ 20 yearsof age at enrollment, any planned alkylator dose is permitted. Eligible patientsmust receive at least one of the alkylators that contribute to CED.

• All patients and/or their parents or legal guardians must sign a written informedconsent.

• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Exclusion Criteria:

• Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to thehypothalamus, inclusive of any total body irradiation (TBI).

• Planned bilateral oophorectomy. Note: A participant's desire to pursue alternativefertility preservation procedures (i.e., embryo, oocyte, or ovarian tissuecryopreservation) will be allowed (and in fact encouraged).

• Congenital syndromes associated with infertility and decreased ovarian reserve atbaseline. For example: Turner's Syndrome, Fragile X premutation carriers, Downsyndrome, etc.

• Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri;history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note:Contact study chairs if questions arise about other pre-existing conditions.

• Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. Incontrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion;oral and other hormonal contraceptive use is also not an exclusion. Note: Please seeprotocol for the concomitant therapy restrictions for patients during the studytreatment period. See protocol for information about oral and other hormonalcontractive use during the study treatment period.

• Prior receipt of systemic chemotherapy. However, steroids and intrathecalchemotherapy are permitted prior to study enrollment.

• Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus,inclusive of any total body irradiation (TBI).

• Patients who are pregnant are not eligible. A pregnancy test is required for femalepatients of childbearing potential.

• Lactating females who plan to breastfeed their infants for the duration oftriptorelin therapy (24 weeks per dose).

• Sexually active patients of reproductive potential who have not agreed to use aneffective contraceptive method for the duration of triptorelin therapy (24 weeks perdose).