Status:
COMPLETED
Hydroxychloroquine and Temsirolimus in Treating Patients With Metastatic Solid Tumors That Have Not Responded to Treatment
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Temsirolimus...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of hydroxychloroquine (HCQ) in combination with temsirolimus (TEM) in patients with metastatic refractory solid tumors. Secondary * Descr...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed refractory solid tumor for which no curative standard therapy exists
- Metastatic disease
- Treated brain metastases that have been stable ≥ 3 months allowed
- At least 1 week since prior steroids
- PATIENT CHARACTERISTICS:
- ECOG performance status of 0-1
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Creatinine ≤ 2 times upper limit of normal (ULN)
- ALT and AST ≤ 5 times ULN
- Total bilirubin ≤ 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious concurrent infection or medical illness that would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety
- No prior or other concurrent malignancy except for curatively treated carcinoma-in-situ at any site or basal cell carcinoma or squamous cell carcinoma of the skin
- Patients who have been free of disease (any prior malignancy) for ≥ 5 years are eligible
- No porphyria
- No psoriasis, except well controlled psoriasis under the care of a specialist
- No previously documented macular degeneration or diabetic retinopathy
- No HIV positivity
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Any number and type of prior anticancer therapies allowed
- No prior mTOR inhibitors
- At least 4 weeks since prior immunotherapy (i.e., aldesleukin, interferon, CTLA-4) or chemotherapy and recovered
- At least 2 weeks since prior oral targeted therapy and recovered
- At least 4 weeks since prior and no other concurrent investigational anticancer therapy (except for vaccines)
- No other concurrent therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs (i.e., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)
- Concurrent non-enzyme inducing anticonvulsants, including felbamate, valproic acid, gabapentin, lamotrigine, tiagabine, topiramate, zonisamide, or levetiracetam allowed
- Concurrent hematologic growth factors (filgrastim \[G-CSF\], pegfilgrastim, epoetin alfa) allowed in patients with severe myelosuppression
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00909831
Start Date
October 1 2008
End Date
November 1 2013
Last Update
April 16 2019
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283