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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01448 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NCI-6186 | |||
| OSU-0347 | |||
| CDR0000355767 | |||
| OSU-2003C0090 | |||
| 0347 | Other Identifier | Ohio State University Medical Center | |
| 6186 | Other Identifier | CTEP | |
| R21CA112894 | U.S. NIH Grant/Contract | View source | |
| N01CM62207 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (temsirolimus) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temsirolimus | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with objective overall response rate (PR+CR) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Time from the initial administration of temsirolimus to first documentation of disease progression or death, assessed up to 5 years | |
| Incidence of toxicities | Up to 5 years |
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Inclusion Criteria:
Diagnosis of multiple myeloma (MM)
Meets at least 1 major AND 1 minor criterion OR at least 3 minor criteria
The following are considered major criteria:
The following are considered minor criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Michael Grever | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| pharmacological study | Other | Correlative studies |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C401859 | temsirolimus |
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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