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

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
O6-benzylguanine
carmustine
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois at Chicago
  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • Cancer Care Specialists of Central Illinois, S.C.
  • Evanston Northwestern Health Care
  • Division of Hematology/Oncology
  • Oncology/Hematology Associates of Central Illinois, P.C.
  • Central Illinois Hematology Oncology Center
  • Fort Wayne Medical Oncology and Hematology, Inc.
  • Michiana Hematology/Oncology P.C.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

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.

Outcomes

Primary Outcome Measures

Disease response

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
September 4, 2013
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005066
Brief Title
O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma
Official Title
A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Advanced Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
September 2001 (Actual)
Study Completion Date
October 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
O6-benzylguanine
Intervention Type
Drug
Intervention Name(s)
carmustine
Primary Outcome Measure Information:
Title
Disease response
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter M. Stadler, MD, FACP
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois, S.C.
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Evanston Northwestern Health Care
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Division of Hematology/Oncology
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Oncology/Hematology Associates of Central Illinois, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
Michiana Hematology/Oncology P.C.
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States

12. IPD Sharing Statement

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

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