Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have rhabdomyosarcoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Camptothecin; Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Irinotecan; Liposomal doxorubicin; Sargramostim; Tirapazamine; Vincristine

Criteria

Inclusion Criteria:

• Histologically confirmed rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma

• First relapse or first occurrence of disease progression

• Unfavorable-risk patients eligible for study window therapy with irinotecan and vincristine meeting the following criteria:

• Unfavorable risk defined by any of the following:

• Embryonal histology with stage I or group I at initial diagnosis with distant recurrence or with local or regional recurrence after prior cyclophosphamide

• Embryonal histology with initial stage II, III, or IV or group II, III, or IV with any relapse pattern

• Alveolar histology with any stage or group at initial diagnosis

• At least unidimensionally measurable disease

• No prior irinotecan

• Bone marrow must not be only site of relapse

• Unfavorable-risk patients ineligible for study window therapy with irinotecan meeting the following criteria:

• Either no measurable disease OR patient received prior irinotecan

• Bone marrow as only site of relapse allowed

• Favorable-risk patients meeting the following criteria:

• Initial botryoid histology (any stage, any group, or any pattern of relapse)

• Embryonal histology if either stage I or group I (with either local or regional recurrence)

• No prior cyclophosphamide

• No CNS metastases

• Performance status - ECOG 0-2

• Performance status - Zubrod 0-2

• At least 2 months

• Absolute neutrophil count at least 750/mm^3

• Platelet count at least 75,000/mm^3 (transfusion independent)

• Hemoglobin at least 10.0 g/dL (red blood cell transfusion allowed)

• Bilirubin no greater than 1.5 times normal

• SGPT less than 2.5 times normal

• Creatinine no greater than 1.5 times normal

• Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

• Shortening fraction at least 27% by echocardiogram

• Ejection fraction at least 50% by MUGA

• No prior ischemic heart disease

• Seizure disorder allowed if well controlled by anticonvulsants

• No CNS toxicity greater than grade 2

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior myeloablative therapy with stem cell transplantation

• At least 1 week since prior antineoplastic biologic agent

• At least 1 week since prior growth factor(s)

• Recovered from prior immunotherapy

• No concurrent immunomodulating agents

• See Disease Characteristics

• See Biologic therapy

• No more than 1 prior chemotherapy regimen

• No prior doxorubicin or daunorubicin

• At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered

• No other concurrent anticancer chemotherapy

• Concurrent corticosteroid therapy allowed

• At least 2 weeks since prior small-port radiotherapy.

• At least 6 months since prior radiotherapy to 50% or more of pelvis

• At least 6 weeks since other prior substantial radiotherapy to bone marrow

• Recovered from prior radiotherapy

• Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated

• No concurrent intensity-modulated radiotherapy