Talotrexin in Treating Patients With Advanced or Recurrent Solid Tumors

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I trial is studying side effects, best way to give, and best dose of talotrexin in treating patients with advanced or recurrent solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of malignant solid tumor

• Metastatic or inoperable disease

• No known curative or survival-prolonging palliative therapy exists OR failed these prior therapies

• No leukemia

• No primary CNS tumor

• No third-space fluid collection (i.e., pleural effusion, ascites)

• Clinically insignificant small pleural or peritoneal effusions identified by CT scan, MRI, or other diagnostic test allowed

• No active* brain metastases, including the following:

• Evidence of cerebral edema by CT scan or MRI

• Progression since prior imaging study

• Requirement for steroids

• Clinical symptoms of/from brain metastases NOTE: *Treated and/or stable brain metastasis allowed provided patient is asymptomatic

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 2 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• RBC folate ≥ lower limit of normal

Hepatic

• Bilirubin normal

• SGOT and SGPT ≤ 2.5 times upper limit of normal

Renal

• Creatinine clearance ≥ 50 mL/min

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other uncontrolled serious medical or psychiatric illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior bone marrow transplantation

Chemotherapy

• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• More than 3 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery

• At least 3 weeks since prior surgery

Other

• Recovered from prior therapy

• More than 3 weeks since prior antifolate therapy