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Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment

Phase 2
15 Years
Not Enrolling
Gastrointestinal Stromal Tumor, Sarcoma

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Trial Information

Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment


- Determine the antitumor activity of brostallicin, in terms of objective response, in
patients with locally advanced or metastatic soft tissue sarcoma who have failed one
prior chemotherapy treatment.

- Determine the time to progression and duration of response in patients treated with
this drug.

- Determine the safety and toxic effects of this drug in these patients.

- Correlate clinical outcome with whole blood glutathione level in patients treated with
this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor (tumors
other than gastrointestinal stromal tumor (GIST) vs GIST).

Patients receive brostallicin IV over 10 minutes on day 1. Treatment repeats every 21 days
for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year and then every 4 months for 1 year.

PROJECTED ACCRUAL: A total of 58-72 patients (40 for stratum I and 18-32 for stratum II)
will be accrued for this study.

Inclusion Criteria


- 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



- Over 15

Performance status:

- WHO 0-1

Life expectancy:

- Not specified


- WBC at least 4,000/mm^3

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


- 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


- Creatinine no greater than 1.4 mg/dL OR

- Creatinine clearance greater than 65 mL/min


- No prior severe cardiovascular disease


- Not pregnant

- Negative pregnancy test

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

- 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


Biologic therapy:

- No concurrent biologic response modifiers or immunotherapy

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


- 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


- See Disease Characteristics

- Recovered from prior radiotherapy

- No prior radiotherapy to sole measurable lesion

- Concurrent palliative radiotherapy to nontarget lesions allowed at investigator's


- See Disease Characteristics

- Recovered from prior surgery


- No other concurrent anticancer therapy (approved or investigational)

- No concurrent participation in any other clinical treatment study

- No other concurrent investigational drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael Leahy, MBChB, FRACP, FRCP, FRC Path

Investigator Role:

Study Chair

Investigator Affiliation:

Fremantle Hospital


United States: Federal Government

Study ID:




Start Date:

May 2002

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • Sarcoma
  • adult angiosarcoma
  • adult fibrosarcoma
  • adult leiomyosarcoma
  • adult liposarcoma
  • adult neurofibrosarcoma
  • adult synovial sarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • adult malignant fibrous histiocytoma
  • adult malignant hemangiopericytoma
  • adult rhabdomyosarcoma
  • gastrointestinal stromal tumor
  • stage IV adult soft tissue sarcoma
  • Gastrointestinal Stromal Tumors
  • Sarcoma