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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00086970 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as ifosfamide and O(6)-benzylguanine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining ifosfamide with O(6)-benzylguanine may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of O(6)-benzylguanine when given together with ifosfamide and to see how well it works compared to ifosfamide alone in treating patients with unresectable metastatic solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Biological: filgrastim Drug: O6-benzylguanine Drug: ifosfamide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study Of BG In Combination With Ifosfamide For Advanced Solid Tumors |
| Study Start Date: | August 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter, dose-escalation study of O6-benzylguanine.
Course 2: Patients are randomized to 1 of 2 treatment arms.
Cohorts of 6-12 patients receive escalating doses of BG (administered as a bolus and as a continuous infusion during course 2) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 or 4 of 12 patients experience dose-limiting toxicity.
In all courses, all patients also receive filgrastim (G-CSF) beginning on day 5 and continuing until blood counts recover.
In all courses and in both arms, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A minimum of 32 patients (at least 2 in arm I and at least 24 in arm II) will be accrued for this study within 12-15 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Study Chair: | Sonali M. Smith, MD | University of Chicago |
More Information
| ClinicalTrials.gov Identifier: | NCT00086970 History of Changes |
| Other Study ID Numbers: | CDR0000371909, UCCRC-12999B, NCI-6461 |
| Study First Received: | July 8, 2004 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific |
|
Neoplasms Ifosfamide Isophosphamide mustard O(6)-benzylguanine Lenograstim Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |