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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00482521
First received: June 4, 2007
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: CC-4047
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: after initial 28 day cycle ] [ Designated as safety issue: Yes ]
    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).

  • Dose-limiting toxicity [ Time Frame: Courses repeat every 28 days for up to 24 months in the absence of unacceptable toxicity. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response as assessed by RECIST criteria [ Time Frame: after every 2 courses (28 days/ course) ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Courses repeat every 28 days for up to 24 months in the absence of disease progression. ] [ Designated as safety issue: No ]
  • Fetal hemoglobin levels as assessed thereafter [ Time Frame: at baseline and every 28 days thereafter ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: March 2007
Study Completion Date: August 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CC-4047 Drug: CC-4047
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482521

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Matthew M. Cooney, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Principal Investigator: Robert Dreicer, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00482521     History of Changes
Other Study ID Numbers: CASE4Y06, P30CA043703, CASE4Y06
Study First Received: June 4, 2007
Last Updated: August 27, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014