CC-4047 in Treating Patients With Advanced Solid Tumors That Did Not Respond to Treatment

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: CC-4047 may stop the growth of tumor cells by blocking blood flow to the tumor.

PURPOSE: This phase I trial is studying the side effects and best dose of CC-4047 in treating patients with advanced solid tumors that did not respond to treatment.

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

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Pomalidomide; Thalidomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced solid tumor

• Refractory disease

• Patients must have been offered and refused OR received and failed prior treatment with all standard or approved therapies for the malignancy

• Measurable or evaluable disease as confirmed by radiographic or clinical evidence

• No curative therapy available

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 3 months

• ANC > 1,500/mm³

• Platelet count > 75,000/mm³

• Hemoglobin ≥ 9.0 g/dL

• Creatinine ≤ 2.0 mg/dL

• AST and ALT < 3 times upper limit of normal

• Not pregnant

• No nursing during and for ≥ 28 days after completion of study treatment

• Two negative pregnancy tests required

• Fertile women must use effective double-method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study treatment

• Men must use a latex condom during sexual contact with fertile females during and for ≥ 28 days after completion of study treatment, even if a prior successful vasectomy was performed

• Stable neurological exam

• No serious medical condition or psychiatric illness that would preclude study participation

• No prior desquamating rash or allergic reaction ≥ grade 2 while taking thalidomide, lenalidomide, or structurally related compounds

• No peripheral neuropathy ≥ grade 2

• No active infection

• No uncontrolled hyper- or hypocalcemia, glycosemia, or thyroidism

PRIOR CONCURRENT THERAPY:

• No prior CC-4047

• More than 28 days since prior cytotoxic chemotherapy (42 days for nitrosoureas)

• At least 14 days since prior therapeutic radiotherapy

• More than 14 days since prior thalidomide, lenalidomide, or structurally related compounds

• More than 14 days since prior biological response modifier therapy

• Concurrent radiotherapy to treat pain associated with existing bone lesions during the extension phase of the study allowed provided < 10% of bone marrow is irradiated

• Concurrent systemic steroids for control of CNS primary tumor and/or metastases symptoms allowed provided dose is stable or decreasing AND patient is also taking low-dose aspirin and/or other platelet-active, anti-thrombotic medication during and for 30 days after completion of study treatment

• No other concurrent chemotherapy or immunotherapy

• No other concurrent investigational agents

• No concurrent hematopoietic growth factors during the treatment phase of the study

• No other concurrent anticancer agents