Ifosfamide and Topotecan in Treating Patients With Refractory Solid Tumors

NCT00003198 | Completed Phase 1

• 3 other identifiers: 97-120CDR0000066034NCI-G98-1376
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 I trial to study the effectiveness of chemotherapy with ifosfamide and topotecan in treating patients with refractory solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

ifosfamide DRUG

topotecan hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor Refractory disease; not curable by surgery, radiation therapy, or standard chemotherapy Measurable or evaluable disease required by evidence of radiographic abnormalities, abnormal physical exam, or elevated tumor markers at least 3 times above normal No brain metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.8 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: No medical or psychiatric conditions Not pregnant Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior topotecan or ifosfamide At least 4 weeks since myelosuppressive chemotherapy At least 6 weeks since nitrosourea or mitomycin Must have recovered from prior therapy Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy to pelvis At least 4 weeks since radiation therapy to major bone marrow containing areas Surgery: Must not have an option of surgery for this disease

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Ifosfamide; Topotecan

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; Camptothecin; Alkaloids

Study Officials

• David R. Spriggs, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 8, 2004
• Study Start: November 1, 1997
• Primary Completion: May 1, 2000
• Study Completion: May 1, 2000
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

US (1)