Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have relapsed or refractory Ewing's sarcoma or peripheral primitive neuroectodermal tumor or desmoplastic small round cell tumor.

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

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Camptothecin; Exatecan

Criteria

DISEASE CHARACTERISTICS:

• One of the following histologically confirmed diagnoses:

• Relapsed or refractory Ewing's sarcoma or primitive neuroectodermal tumor

• Desmoplastic small round cell tumor

• Measurable disease

• The following are not considered measurable disease:

• Ascites

• Pleural effusion

• Lytic bone lesions

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• ECOG 0-2 (over 10 years of age)

• Lansky 60-100% (10 years of age and under)

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 750/mm^3

• Platelet count at least 75,000/mm^3

• Hemoglobin at least 8.5 g/dL

Hepatic

• Bilirubin no greater than 2.0 mg/dL

• AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)

• Albumin at least 2.8 g/dL

Renal

• Creatinine less than 1.5 times ULN

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active serious infection

• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No overt psychosis or mental disability that would preclude informed consent

• No other life-threatening illness within the past 6 months

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 3 months since prior autologous bone marrow or stem cell transplantation

• No concurrent biologic therapy

Chemotherapy

• Recovered from prior systemic chemotherapy

• Prior topoisomerase I inhibitor therapy allowed

• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior cranial, spinal, or whole pelvis radiotherapy

• More than 4 weeks since prior radiotherapy to 25% of bone marrow reserve

• No concurrent radiotherapy

Surgery

• At least 4 weeks since prior major surgery and recovered

• No concurrent surgery

Other

• More than 28 days since prior investigational drugs (including analgesics or antiemetics)

• No more than 2 prior treatment regimens for this disease

• No other investigational drugs during and for 28 days after study therapy

• No other concurrent anticancer therapy

• No concurrent grapefruit or grapefruit juice