Dolastatin 10 in Treating Patients With Recurrent or Metastatic Soft Tissue Sarcoma

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00003778

Collaborator

(none)

Enrollment

Locations

Arm

9.3

Patients Per Site

Study Details

Study Description

Brief Summary

Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have recurrent or metastatic soft tissue sarcoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Sarcoma	Drug: dolastatin 10	Phase 2

Detailed Description

OBJECTIVES:

Determine the response rate in patients with recurrent or metastatic soft tissue sarcomas treated with dolastatin 10.
Determine the toxicity of this regimen in this patient population.

OUTLINE: This is an open label, multicenter study. Patients are stratified according to center, prior therapy, histologic subtype, stage of disease at diagnosis, and current status of disease (recurrent vs metastatic).

Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Dolastatin-10 in Patients With Previously Untreated Recurrent/Metastatic Sarcoma

Study Start Date :

Apr 1, 1999

Actual Primary Completion Date :

Jul 1, 2000

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Drug: dolastatin 10

Arm

Intervention/Treatment

Experimental: Arm I

Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: dolastatin 10

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically proven recurrent or metastatic soft tissue sarcoma
No rhabdomyosarcoma, Ewing's sarcoma, chondrosarcoma, osteogenic sarcoma, mesothelioma, or Kaposi's sarcoma Bidimensionally measurable disease other than previously irradiated disease site(s) even if there has been progression within the radiation field
Pulmonary nodule(s) at least 1 x 1 cm No brain metastases

PATIENT CHARACTERISTICS:

Age: 18 and over
Performance status: ECOG 0 or 1
Absolute neutrophil count at least 2,000/mm3
Platelet count at least 100,000/mm3
Bilirubin no greater than 1.5 mg/dL
AST and ALT less than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases present)
Creatinine no greater than 1.5 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study
No uncontrolled infection
No history of prior malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other malignancy in complete remission

PRIOR CONCURRENT THERAPY:

No more than 1 prior chemotherapy regimen in the adjuvant setting
No prior chemotherapy for metastatic disease
At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
At least 4 weeks since prior radiotherapy
Recovered from prior surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Cancer Center	Denver	Colorado	United States	80262
2	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
3	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210
4	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111