PR104 and G-CSF in Treating Patients With Solid Tumors

• Status: Completed
• Trial end date: 2009-06-01
• 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. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving PR-104 together with G-CSF may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given together with G-CSF in treating patients with solid tumors.

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

Details

• Lead Sponsor: Proacta, Incorporated
• Treatments: Lenograstim; Misonidazole

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumors

• Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-1

• Absolute neutrophil count ≥ 1.5 x 10^9/L

• Platelet count ≥ 100 x 10^9/L

• Hemoglobin ≥ 9 g/dL (no red blood cell transfusions allowed)

• Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

• PTT ≤ 1.5 times normal

• Serum creatinine ≤ 1.5 times ULN

• ALT or AST ≤ 2 times ULN (≤ 5 times ULN if liver metastases are present)

• Not pregnant or nursing

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

• Able to read, understand, and provide written informed consent

Exclusion criteria:

• Evidence of a significant medical disorder or laboratory finding that, in the opinion of the investigator, compromises the patient's safety during study participation, including any of the following:

• Uncontrolled infection or infection requiring a concomitant parenteral antibiotic

• Uncontrolled diabetes

• Congestive heart failure

• Myocardial infarction within the past 6 months

• Chronic renal disease

• Coagulopathy (excluding prophylactic anticoagulation)

• Known HIV positivity

• Hepatitis B sAg-positive or known to be hepatitis C-positive with abnormal liver function tests

PRIOR CONCURRENT THERAPY:

• No more than 3 prior myelosuppressive chemotherapy regimens

• Patients who have received more than 3 prior myelosuppressive regimens may be eligible, if considered to have adequate marrow, based on prior exposure to 1 of the following regimens:

• Minimally myelosuppressive regimens

• Limited courses of myelosuppressive regimens

• More than 4 weeks since prior and no other concurrent licensed or investigational anticancer treatment (6 weeks for nitrosoureas or mitomycin C)

• More than 24 hours since any prior radiotherapy and no likelihood of toxicity from this therapy

• More than 4 weeks since major surgery

• No prior radiotherapy to > 20% of bone marrow

• No prior high-dose chemotherapy (including either myeloablative or non-myeloablative transplantations)

• Prior and concurrent androgen deprivation therapy allowed

• Concurrent systemic steroids allowed, provided the patient has been on a stable dose for at least 2 weeks prior to first dose of PR-104

• No concurrent irradiation therapy (palliative or therapeutic), unless given in the absence of tumor progression