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CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma
This study has been completed.
First Received: March 8, 2004   Last Updated: March 24, 2009   History of Changes
Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00079456
  Purpose

RATIONALE: Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: temsirolimus
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial Of CCI-779 In Patients With Relapsed Or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Incidence of PTEN mutation [ Designated as safety issue: No ]
  • Pharmacodynamics [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: February 2004
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the overall response rate in patients with relapsed or refractory multiple myeloma treated with CCI-779.

Secondary

  • Determine the progression-free survival of patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine the presence of PTEN mutation in patients treated with this drug.
  • Correlate the pharmacokinetics of this drug with response in these patients.
  • Correlate the pharmacodynamic effects of this drug with response in these patients.

OUTLINE: This is an open-label study.

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 8-12.5 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma (MM)

    • Salmon-Durie stage IIA or IIIA OR progressive stage IA disease
  • Meets at least 1 major AND 1 minor criterion OR at least 3 minor criteria

    • The following are considered major criteria:

      • Plasmacytoma on tissue biopsy
      • Bone marrow plasmacytosis with ≥ 30% plasma cells
      • Monoclonal globulin spike on serum protein electrophoresis exceeding 3.5 g/dL for immunoglobulin (Ig) G peaks or 2.0 g/dL for IgA peaks OR the presence of Bence-Jones protein of ≥ 1 g/24 hour-urine collection
    • The following are considered minor criteria:

      • Bone marrow plasmacytosis 10-29%
      • Monoclonal globulin spike present, but less than the levels defined for a major criterion
      • Lytic bone lesion
      • Decrease in normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL
  • No non-secretory MM (absent serum or urinary M-protein)
  • Failed at least 1 prior systemic therapy* (e.g., chemotherapy, high-dose corticosteroids, thalidomide, or bortezomib) for the treatment of MM NOTE: *Patients who receive only radiotherapy or bisphosphonates are not eligible
  • No solitary plasmacytoma

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 6 months

Hematopoietic

  • Absolute neutrophil count > 1,200/mm^3
  • Platelet count > 75,000/mm^3

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Fasting cholesterol ≤ 350 mg/dL
  • Triglycerides ≤ 400 mg/dL
  • No other concurrent uncontrolled illness
  • No active or ongoing infection requiring oral or IV antibiotics
  • No prior allergic reaction to compounds of similar chemical or biological composition to CCI-779
  • No other prior or concurrent malignancy or myelodysplasia except for the following:

    • Basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix
    • Localized cancer treated with surgery only with no evidence of disease for > 5 years
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • See Chemotherapy
  • More than 4 weeks since prior thalidomide and recovered

Chemotherapy

  • See Disease Characteristics
  • Prior high-dose chemotherapy and stem cell transplantation allowed
  • More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy

  • See Disease Characteristics
  • More than 4 weeks since prior high-dose corticosteroids and recovered

Radiotherapy

  • See Disease Characteristics

Other

  • More than 4 weeks since prior bortezomib and recovered
  • More than 4 weeks since other prior anti-myeloma systemic therapy and recovered
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079456

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Investigators
Study Chair: Michael R. Grever, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000355767, OSU-0347, NCI-6186, OSU-2003C0090
Study First Received: March 8, 2004
Last Updated: March 24, 2009
ClinicalTrials.gov Identifier: NCT00079456     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Study placed in the following topic categories:
Immunoproliferative Disorders
Hemorrhagic Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on July 02, 2009