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

A Phase I, Open-Label Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety Profile of CC-4047 in Subjects With Advanced Solid Tumors

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00482521
Enrollment
42
Registered
2007-06-05
Start date
2007-03-31
Completion date
2012-08-31
Last updated
2012-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Brief 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.

Detailed 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.

Interventions

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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Maximum tolerated doseafter initial 28 day cycleTo determine the maximum tolerated dose (MTD) of daily CC-4047 in an initial 28-day cycle (21 days of CC-4047 followed by 7 days of no therapy) in subjects with advanced solid tumors (Cohort A).
Dose-limiting toxicityCourses repeat every 28 days for up to 24 months in the absence of unacceptable toxicity.

Secondary

MeasureTime frame
Tumor response as assessed by RECIST criteriaafter every 2 courses (28 days/ course)
Duration of responseCourses repeat every 28 days for up to 24 months in the absence of disease progression.
Fetal hemoglobin levels as assessed thereafterat baseline and every 28 days thereafter

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026