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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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Rapamycin is a drug that has been approved by the Food and Drug Administration (government) for use in patients receiving a kidney transplant to prevent the patient's body from rejecting the transplanted kidney. It has shown antitumor effects in the laboratory, but has not been approved at this time for the treatment of cancer. Abraxane is a new form of chemotherapy that has been approved by the Food and Drug Administration for the treatment of metastatic breast cancer, and is a promising drug that is being evaluated in clinical trials for treatment of other cancers. This is a phase I study designed to find out if different doses of Rapamycin, when combined with Abraxane, are safe and well tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapamune | Drug | Dose escalation as follows: 5mg PO, 10mg PO, 20mg PO, 40mg PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety, dose-limiting toxicities, and maximum tolerated dose of weekly oral Rapamycin in combination with weekly intravenous Abraxane for three out of four consecutive weeks in patients with advanced solid cancers. | upon completion of study |
| Measure | Description | Time Frame |
|---|---|---|
| to determine if weekly administration of Rapamycin changes the pharmacokinetic profile of weekly Abraxane | upon completion of study | |
| To determine pre and post therapy changes in p70S6K in peripheral mononuclear cells in patients treated with oral Rapamycin and Abraxane |
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Inclusion Criteria:
Hemoglobin ≥ 9 g/dL leukocytes ≥3,000/mcL absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT)2.5 X institutional upper limit of normal creatinine within 1.5 x ULN OR creatinine clearance ≥50 mL/min/1.73 m² for patients with creatinine levels ≥1.5 ULN.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maysa Abu-Khalaf, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Comprehensive Cancer Center at Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D017239 | Paclitaxel |
| D043823 |
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| Abraxane | Drug | intravenous administration of 100mg/m2 Abraxane over 30 minutes, weekly for three out of four consecutive weeks. |
|
|
| Upon completion of study |
| To evaluate changes in the phosphorylation of p70S6K on tumor tissue and to determine the correlation with phosphorylation of p70S6K in the peripheral mononuclear cells, in patients who give consent to pre and post tumor biopsies | upon completion of study |
| Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |