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

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Completed

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: CC-4047

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00482521

P30CA043703 (U.S. NIH Grant/Contract)

CASE4Y06 (Other Identifier)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

Determine the maximum tolerated dose of CC-4047 in patients with advanced refractory solid tumors.

Secondary

Assess the safety of this drug in these patients.
Assess the antitumor activity of this drug in these patients.
Determine the effect of this drug on fetal hemoglobin levels in these patients.

OUTLINE: This is a open-label, uncontrolled, nonrandomized, dose-escalation, multicenter study.

Treatment phase (course 1): Patients receive oral CC-4047 once daily on days 1-21 followed by a 7-day recovery period.

Cohorts of 3-6 patients receive escalating doses of CC-4047 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).

Patients with no clinical evidence of progressive disease or DLT after course 1 continue study treatment during the extension phase. Patients who develop a DLT during course 1 may continue study treatment at the discretion of the investigator.

Extension phase: Patients continue taking CC-4047 at their assigned cohort dose as in course 1. Patients who tolerate a treatment-phase dose higher than the MTD continue treatment at the MTD. Courses repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline and periodically during study to evaluate fetal hemoglobin levels.

After completion of study treatment, patients are followed at 28 days.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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