Hydroxychloroquine and Temsirolimus in Treating Patients With Metastatic Solid Tumors That Have Not Responded to Treatment

NCT00909831 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000643294UPCC-08908807931WYETH-C-UPCC-03809
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with temsirolimus may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of hydroxychloroquine when given together with temsirolimus in treating patients with metastatic solid tumors that have not responded to treatment.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of hydroxychloroquine

Secondary Outcomes (3)

• Response rate

• Toxicity rate as assessed by NCI CTCAE v. 3.0

• Pharmacokinetic and pharmacodynamic correlative endpoints

Interventions

hydroxychloroquine DRUG

temsirolimus DRUG

electron microscopy OTHER

high performance liquid chromatography OTHER

immunologic technique OTHER

laboratory biomarker analysis OTHER

mass spectrometry OTHER

pharmacological study OTHER

autophagy inhibition therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Interventions

Hydroxychloroquine; temsirolimus; Microscopy, Electron; Chromatography, High Pressure Liquid; Immunologic Techniques; Mass Spectrometry

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Chromatography, Liquid; Chromatography; Chemistry Techniques, Analytical

Study Officials

• Ravi Amaravadi, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: May 29, 2009
• Study Start: October 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: November 1, 2013
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)