Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Solid Tumors

NCT00024661 | Completed Phase 1

• 1 other identifier: LErafAON-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

LErafAON is a liposome encapsulated c-raf antisense oligonucleotide. Raf-1 is a protein produced by human cells, both normal and cancerous, which may help protect tumor cells from radiation. Antisense oligonucleotides are very specific drugs, which can decrease the amount of a certain target protein by blocking the gene that makes it. Antisense oligonucleotide to raf gene can reduce the amount of Raf-1 protein in tumor cells. Liposomes are tiny globules of fat, which can carry drugs in the body. The experimental agent LErafAON is composed of liposomes carrying antisense oligonucleotide against the Raf-1 protein. It is hoped that decreased Raf-1 in the cancer cells will make them more sensitive to the radiation therapy. Patients with advanced solid tumors will receive IV infusions of LErafAON over at least 60 minutes, once per week, for 8 weeks. In the absence of progression, patients may continue on weekly treatment. Pre-medications will be administered prior to each dose of study medication. Cohorts of at least three patients will be entered at escalating dose-levels. Each cohort will be observed for at least ten days after receiving the first dose of treatment before additional patients are treated at a higher dose level. Patients will be followed for one month after receiving the last dose of study medication. The study will stop when a maximum tolerated dose (MTD) is identified. Dose escalation within a patient will not be allowed.

Conditions

Neoplasms

Keywords

recurrent solid tumors; liposomes containing AON to c-raf protein (LErafAON)

Interventions

LErafAON DRUG

Eligibility Criteria

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

-Disease Characteristics- Histologically-confirmed malignancy which has recurred or progressed after initial definitive treatment and/or for which no curative therapy is available. At least 30 days must have elapsed since receiving an investigational agent, at least 21 days since receiving any prior chemotherapy, and at least six weeks since receiving nitrosourea-containing therapy; patient must have recovered from any related side effects. Must have a measurable or evaluable tumor documented within 4 weeks prior to having study-related procedures. -Patient Characteristics- Performance Status (ECOG) of 0 - 2. Must be at least 18 years of age. Must have adequate organ function: Absolute neutrophil count at least 1,500/mm3; Platelets at least 100,000/mm3; Creatinine, Calcium, and total Bilirubin not higher than the upper limit of normal; Liver enzymes AST and ALT not more than 2.5 x the upper limit of normal; PT and aPTT not more than the upper limit of normal. Life expectancy more than 12 weeks. Must sign Informed Consent. No concurrent antitumor therapy. No infection requiring parenteral antibiotics; no HIV infection; no chronic hepatic disease; and no seropositivity for Hepatitis B and Hepatitis C. (Use of prophylactic antibiotics is permitted.) No pregnant or lactating females. All females of child-bearing potential must use an effective method of contraception. No active Central Nervous System (CNS) metastasis. Neuroimaging is required only if metastasis is suggested by history or physical examination.

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

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead
• Georgetown University: collaborator

Study Sites (3)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Temple University Cancer Center

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

LErafAON

Study Officials

• Charles Rudin, M.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2001
• First Posted: September 25, 2001
• Study Start: March 1, 2001
• Study Completion: October 1, 2004
• Last Updated: April 13, 2011

Record last verified: 2011-04

Locations

US (3)