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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00079456
Other study ID # NCI-2012-01448
Secondary ID NCI-2012-01448NC
Status Completed
Phase Phase 2
First received March 8, 2004
Last updated October 10, 2013
Start date February 2004

Study information

Verified date October 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This phase II trial is studying how well temsirolimus works in treating patients with relapsed or refractory multiple myeloma. Drugs used in chemotherapy such as temsirolimus work in different ways to stop cancer cells from dividing so they stop growing or die.


Description:

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. Determine the progression-free survival of patients treated with this drug. II. Determine the toxicity of this drug in these patients. III. Determine the presence of PTEN mutation in patients treated with this drug.

IV. Correlate the pharmacokinetics of this drug with response in these patients.

V. Correlate the pharmacodynamic effects of this drug with response in these patients.

OUTLINE: This is an open-label study.

Patients receive temsirolimus 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

- No solitary plasmacytoma

- Performance status - ECOG 0-2

- More than 6 months

- Absolute neutrophil count > 1,200/mm^3

- Platelet count > 75,000/mm^3

- AST and ALT =< 2.5 times upper limit of normal (ULN)

- Bilirubin =< 1.5 times ULN

- Creatinine =< 1.5 times ULN

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- 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

- More than 4 weeks since prior thalidomide and recovered

- Prior high-dose chemotherapy and stem cell transplantation allowed

- More than 4 weeks since prior chemotherapy and recovered

- More than 4 weeks since prior high-dose corticosteroids and recovered

- 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
temsirolimus
Given IV
Other:
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio
United States Ohio State University Medical Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with objective overall response rate (PR+CR) Up to 5 years No
Secondary Progression-free survival Time from the initial administration of temsirolimus to first documentation of disease progression or death, assessed up to 5 years No
Secondary Incidence of toxicities Up to 5 years Yes
See also
  Status Clinical Trial Phase
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Terminated NCT02020941 - Carfilzomib in Treating Patients With Multiple Myeloma in First Relapse or Refractory to First-Line Therapy Phase 2
Completed NCT01212952 - Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Phase 1/Phase 2
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