PR-104 in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as PR-104, 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 the side effects and best dose of PR-104 in treating patients with advanced solid tumors.

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

Details

• Lead Sponsor: Proacta, Incorporated
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumor, meeting 1 of the following criteria:

• Not amenable to standard therapy

• Refractory to conventional therapy

• Measurable or evaluable disease

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Life expectancy > 3 months

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin > 9 g/L (transfusion independent)

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT and AST ≤ 2.5 times ULN

• Creatinine clearance ≥ 60 mL/min

• PT/INR or aPTT ≤ 1.1 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 30 days after completion of study treatment

• No significant cardiac comorbidity including any of the following:

• New York Heart Association class III-IV congenital heart failure

• LVEF < 40%

• Unstable angina

• Myocardial infarction within the past 6 months

• Ventricular arrhythmias requiring drug therapy

• Pacemaker or implanted defibrillator

• No ongoing coagulopathy

• No uncontrolled infection or infection requiring parenteral antibiotics

• No other significant clinical disorder or laboratory finding that would preclude study treatment

• No known HIV positivity

• No known positivity for hepatitis B surface antigen or hepatitis C with abnormal liver tests

• No known allergy to nonplatinum-containing alkylating agents

PRIOR CONCURRENT THERAPY:

• Recovered from prior therapy

• More than 2 weeks since prior hormonal therapy (except for androgen-deprivation therapy)

• More than 4 weeks since prior major surgery

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

• More than 4 weeks since prior radiotherapy

• More than 1 month since prior investigational drugs, therapies, or devices

• No prior radiotherapy to > 25% of bone marrow

• No prior high-dose chemotherapy, either myeloablative or nonmyeloablative (mini-allogeneic transplant)

• No more than 3 prior myelosuppressive chemotherapy regimens

• Concurrent steroids allowed provided dose is stable for ≥ 2 weeks and clinical condition is stable for 1 month

• Nasal, opthalmologic, and topical glucocorticoid preparations allowed

• Physiologic hormone replacement therapies allowed (i.e., oral replacement glucocorticoid therapy for adrenal insufficiency)

• No concurrent prophylactic hematopoietic growth factors

• No concurrent radiotherapy, including local palliative radiotherapy or systemic radioisotopes

• Radioisotopes for protocol specified positron emission tomography allowed

• No other concurrent investigational agents

• No other concurrent chemotherapy, radiotherapy (including palliative local radiotherapy), hormonal therapy (except for androgen-deprivation therapy), and/or biological therapy (including immunotherapy)