O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma

September 4, 2013 updated by: University of Chicago

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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining O6-benzylguanine and carmustine in treating patients who have recurrent, metastatic, or locally advanced soft tissue sarcoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60640
        • Louis A. Weiss Memorial Hospital
      • Chicago, Illinois, United States, 60637
        • University of Chicago Cancer Research Center
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Central Illinois, S.C.
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Health Care
      • Park Ridge, Illinois, United States, 60068
        • Division of Hematology/Oncology
      • Peoria, Illinois, United States, 61602
        • Oncology/Hematology Associates of Central Illinois, P.C.
      • Springfield, Illinois, United States, 62701
        • Central Illinois Hematology Oncology Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46885-5099
        • Fort Wayne Medical Oncology and Hematology, Inc.
      • South Bend, Indiana, United States, 46617
        • Michiana Hematology/Oncology P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
O6-BG as an intravenous infusion (through your vein) over 1 hour followed 1 hour later by BCNU intravenously over 15 minutes. chemotherapy every 6 weeks.
Drug: O6-benzylguanine
Drug: carmustine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease response
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (Actual)

September 1, 2001

Study Completion (Actual)

October 1, 2002

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

April 9, 2004

First Posted (Estimate)

April 12, 2004

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10227
  • UCCRC-10227
  • UCCRC-T99-0088
  • NCI-T99-0088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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