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

NCT00482521 | Completed Phase 1 DMC

• 2 other identifiers: CASE4Y06P30CA043703
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  To 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).

  after initial 28 day cycle

• Dose-limiting toxicity

  Courses repeat every 28 days for up to 24 months in the absence of unacceptable toxicity.

Secondary Outcomes (3)

• Tumor response as assessed by RECIST criteria

  after every 2 courses (28 days/ course)

• Duration of response

  Courses repeat every 28 days for up to 24 months in the absence of disease progression.

• Fetal hemoglobin levels as assessed thereafter

  at baseline and every 28 days thereafter

Study Arms (1)

CC-4047

EXPERIMENTAL

Drug: CC-4047

Interventions

CC-4047 DRUG

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.

CC-4047

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

pomalidomide

Study Officials

• Matthew M. Cooney, MD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  STUDY CHAIR

• Robert Dreicer, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: March 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: August 1, 2012
• Last Updated: August 28, 2012

Record last verified: 2012-08

Locations

US (2)