Ifosfamide With or Without O(6)-Benzylguanine in Treating Patients With Unresectable, Metastatic Solid Tumors

NCT00086970 | Terminated Phase 1

• 4 other identifiers: NCI-2012-0260112999BU01CA069852CDR0000371909
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

• Change in degree of myelosuppression (thrombocytopenia and neutropenia) quantified by both duration of neutropenia and severity of neutropenia

  Baseline up to 1 year

• Maximum tolerated dose (MTD) of O6-benzylguanine defined as the dose preceding that at which 3 of 6 or 4 of 12 patients experience dose-limiting toxicity

  DLT is defined as any \>= grade 3 non-hematologic toxicity, grade 4 thrombocytopenia, or prolonged neutropenia.

  21 days

Secondary Outcomes (2)

• Pharmacodynamics including apoptosis and DNA damage

  Up to 1 year

• Pharmacokinetics of O6-benzylguanine

  Up to day 3 of course 2

Study Arms (2)

Arm I (ifosfamide)

EXPERIMENTAL

Patients receive high-dose ifosfamide IV continuously over 72 hours on days 1-3.

Drug: ifosfamide

Arm II (O6-benzylguanine, ifosfamide)

EXPERIMENTAL

Patients receive a bolus dose of O6-benzylguanine (BG) IV over 1 hour on day 1 followed by BG IV continuously and high-dose ifosfamide IV continuously over 72 hours on days 1-3.

Drug: ifosfamide; Drug: O6-benzylguanine

Interventions

ifosfamide DRUG

Given IV

Also known as: Cyfos, Holoxan, IFF, IFX, IPP

Arm I (ifosfamide); Arm II (O6-benzylguanine, ifosfamide)

O6-benzylguanine DRUG

Given IV

Also known as: BG

Arm II (O6-benzylguanine, ifosfamide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed solid tumor
• Unresectable, metastatic disease
• No primary tumors
• Eligible for high-dose ifosfamide-based therapy
• No known brain metastases
• Performance status - ECOG 0-1
• Performance status - Karnofsky 70-100%
• More than 12 weeks
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• AST and ALT ≤ 2.5 times upper limit of normal
• Bilirubin normal
• Creatinine normal
• Creatinine clearance ≥ 60 mL/min
• No symptomatic congestive heart failure

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Interventions

Ifosfamide; indolepropanol phosphate; O(6)-benzylguanine

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sonali Smith

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: June 1, 2004
• Primary Completion: November 1, 2005
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (1)