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A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Advanced Soft Tissue Sarcoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Advanced Soft Tissue Sarcoma


OBJECTIVES: I. Determine the objective response rate of patients with recurrent, metastatic,
or locally advanced soft tissue sarcoma treated with O6-benzylguanine and carmustine. II.
Determine the toxicity of this regimen in this patient population. III. Determine the
duration of response, time to progression, and survival of these patients treated with this
regimen.

OUTLINE: Patients receive O6-benzylguanine IV over 1 hour followed 1 hour later by
carmustine IV over 15 minutes. Treatment continues every 6 weeks for a minimum of 2 courses
in the absence of unacceptable toxicity or disease progression. Patients with progressive
disease are followed every 6 months until death. Patients without progressive disease are
followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 14
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent, metastatic,
or locally advanced soft tissue sarcoma considered incurable by surgery or radiotherapy
Bidimensionally measurable disease At least 1 cm x 1 cm, with clearly defined margins on
CT scan, X-ray, or physical examination Located outside of radiation port or evidence of
progression within radiation port No CNS disease only No uncontrolled symptomatic brain
metastases regardless of other disease sites

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal unless due to
Gilbert's syndrome SGOT or SGPT no greater than 2 times upper limit of normal Renal:
Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Pulmonary:
DLCO at least 80% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception No other concurrent significant underlying
medical or psychiatric illness (e.g., active infection) that would preclude study
treatment or exceptionally increase risk of toxicities No other prior malignancy within
the past 5 years except curatively treated nonmelanoma skin cancer, carcinoma in situ of
the cervix, or superficial bladder cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for metastatic disease At least 4 weeks since prior neoadjuvant and/or
adjuvant chemotherapy No other concurrent chemotherapy No concurrent investigational
antineoplastic drugs Endocrine therapy: Not specified Radiotherapy: See Disease
Characteristics At least 3 weeks since prior radiotherapy and recovered No concurrent
radiotherapy to any lesion Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease response

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Walter M. Stadler, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

10227

NCT ID:

NCT00005066

Start Date:

June 2000

Completion Date:

October 2002

Related Keywords:

  • Sarcoma
  • recurrent adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Sarcoma

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Evanston Northwestern Health CareEvanston, Illinois  60201
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
University of Illinois at ChicagoChicago, Illinois  60612
Cancer Care Specialists of Central Illinois, S.C.Decatur, Illinois  62526
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Central Illinois Hematology Oncology CenterSpringfield, Illinois  62701
Fort Wayne Medical Oncology and Hematology, Inc.Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C.South Bend, Indiana  46617
Division of Hematology/OncologyPark Ridge, Illinois  60068