PR-104 in Treating Patients With Advanced Solid Tumors

NCT00349167 | Completed Phase 1

• 4 other identifiers: PR104-1001P30CA016042UCLA-0512034-01APROACTA-PR-104-1001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 in treating patients with advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (1)

PR-104

EXPERIMENTAL

PR104 was administered as a 1-hr IV infusion every 21 days at doses ranging from 135 to 1400 mg/m2

Drug: PR-104; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

PR-104 DRUG

PR-104

laboratory biomarker analysis OTHER

PR-104

pharmacological study OTHER

PR-104

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor, meeting 1 of the following criteria: * Not amenable to standard therapy * Refractory to conventional therapy * Measurable or evaluable disease PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Life expectancy \> 3 months * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin \> 9 g/L (transfusion independent) * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT and AST ≤ 2.5 times ULN * Creatinine clearance ≥ 60 mL/min * PT/INR or aPTT ≤ 1.1 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after completion of study treatment * No significant cardiac comorbidity including any of the following: * New York Heart Association class III-IV congenital heart failure * LVEF \< 40% * Unstable angina * Myocardial infarction within the past 6 months * Ventricular arrhythmias requiring drug therapy * Pacemaker or implanted defibrillator * No ongoing coagulopathy * No uncontrolled infection or infection requiring parenteral antibiotics * No other significant clinical disorder or laboratory finding that would preclude study treatment * No known HIV positivity * No known positivity for hepatitis B surface antigen or hepatitis C with abnormal liver tests * No known allergy to nonplatinum-containing alkylating agents PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * More than 2 weeks since prior hormonal therapy (except for androgen-deprivation therapy) * More than 4 weeks since prior major surgery * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) * More than 4 weeks since prior radiotherapy * More than 1 month since prior investigational drugs, therapies, or devices * No prior radiotherapy to \> 25% of bone marrow * No prior high-dose chemotherapy, either myeloablative or nonmyeloablative (mini-allogeneic transplant) * No more than 3 prior myelosuppressive chemotherapy regimens * Concurrent steroids allowed provided dose is stable for ≥ 2 weeks and clinical condition is stable for 1 month * Nasal, opthalmologic, and topical glucocorticoid preparations allowed * Physiologic hormone replacement therapies allowed (i.e., oral replacement glucocorticoid therapy for adrenal insufficiency) * No concurrent prophylactic hematopoietic growth factors * No concurrent radiotherapy, including local palliative radiotherapy or systemic radioisotopes * Radioisotopes for protocol specified positron emission tomography allowed * No other concurrent investigational agents * No other concurrent chemotherapy, radiotherapy (including palliative local radiotherapy), hormonal therapy (except for androgen-deprivation therapy), and/or biological therapy (including immunotherapy)

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

Sponsors & Collaborators

• Proacta, Incorporated: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

• Jameson MB, Rischin D, Pegram M, Gutheil J, Patterson AV, Denny WA, Wilson WR. A phase I trial of PR-104, a nitrogen mustard prodrug activated by both hypoxia and aldo-keto reductase 1C3, in patients with solid tumors. Cancer Chemother Pharmacol. 2010 Mar;65(4):791-801. doi: 10.1007/s00280-009-1188-1. Epub 2009 Dec 10.

  PMID: 20012293 RESULT

MeSH Terms

Interventions

PR-104

Study Officials

• Mark D. Pegram, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 6, 2006
• Study Start: December 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: November 30, 2012

Record last verified: 2012-11

Locations

US (1)