Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

• Status: Completed
• Trial end date: 1969-12-31
• 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 brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.

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

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed soft tissue sarcoma that is not amenable to surgery, radiotherapy, or combined modality therapy with curative intent

• Stratum I

• Malignant fibrous histiocytoma

• Liposarcoma

• Rhabdomyosarcoma

• Synovial sarcoma

• Malignant paraganglioma

• Fibrosarcoma

• Leiomyosarcoma

• Angiosarcoma including hemangiopericytoma

• Malignant peripheral nerve sheath tumor

• Unclassified sarcoma

• Miscellaneous sarcoma

• Stratum II

• Gastrointestinal stromal tumor

• Previously treated with imatinib mesylate for locally advanced or metastatic disease and demonstrated disease progression

• The following sarcoma types are excluded:

• Mixed mesodermal tumors of the uterus (and carcinosarcoma)

• Chondrosarcoma

• Malignant mesothelioma

• Neuroblastoma

• Osteosarcoma

• Ewing's sarcoma

• Embryonal rhabdomyosarcoma

• At least one measurable lesion

• Progressive disease after 1 prior anthracycline- and/or alkylating-containing chemotherapy regimen for locally advanced or metastatic disease

• Clinical evidence of progression within 6 weeks prior to study treatment

• No known or symptomatic CNS metastases

PATIENT CHARACTERISTICS:

Age:

• Over 15

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)

• SGPT and SGOT no greater than 3 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.4 mg/dL OR

• Creatinine clearance greater than 65 mL/min

Cardiovascular:

• No prior severe cardiovascular disease

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception during and for up to 6 months after study

• No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix

• No other severe medical illness

• No psychosis

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent biologic response modifiers or immunotherapy

• No concurrent prophylactic hematopoietic growth factors (e.g., filgrastim (G- CSF) or sargramostim (GM-CSF)

Chemotherapy:

• See Disease Characteristics

• More than 4 weeks since prior chemotherapy and recovered

• Prior adjuvant chemotherapy as first-line treatment allowed provided disease progressed within 6 months after the completion of chemotherapy

• No prior ecteinascidin 743 (stratum I)

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy

Radiotherapy:

• See Disease Characteristics

• Recovered from prior radiotherapy

• No prior radiotherapy to sole measurable lesion

• Concurrent palliative radiotherapy to nontarget lesions allowed at investigator's discretion

Surgery:

• See Disease Characteristics

• Recovered from prior surgery

Other:

• No other concurrent anticancer therapy (approved or investigational)

• No concurrent participation in any other clinical treatment study

• No other concurrent investigational drugs