Protocol Number: 07-C-0200

Title:

A Phase 1, Multicenter, Dose-Escalation Study of CAT-8015 in Patients with Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

Number:

07-C-0200

Summary:

Background:

-The experimental drug CAT-8015 consists of two parts: an antibody that binds to a protein called CD22, which may be found on the surface of cancer cells; and a toxin (a type of poison).

-In laboratory experiments, CAT-8015 has been shown to kill leukemia cells that have the CD22 protein and to decrease tumors in mice.

Objectives:

-To determine the highest dose of CAT-8015 that can safely be given to patients with non-Hodgkin's lymphoma.

-To learn how CAT-8015 is handled by the body.

Eligibility:

-Patients with non-Hodgkin's lymphoma that have not responded to standard treatment, including chemotherapy, surgery or radiation therapy.

-Patients must have a protein called CD22 on the surface of their cancer cells.

Design:

-The first three to six patients enrolled in this dose escalation study take the smallest study dose of CAT-8015. If they do not develop significant adverse side effects, successive small groups of patients take the drug at increasingly higher doses until the MTD is reached. Once the MTD is determined, newly enrolled patients are given that dose.

-CAT-8015 is given in 4-week treatment cycles. Each cycle consists of a 30-minute infusion of the drug into a vein every other day for 3 doses (days 1, 3, 5). This is followed by a rest period (no drug) until the start of the next cycle.

-Patients are evaluated with periodically with physical examinations, blood and urine tests and CT scans during the treatment period and for 24 months after completing the last treatment cycle. Additional tests, such as a bone marrow aspirate and biopsy, are done as needed.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Clinical hold/Recruitment or enrollment suspended

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Recombinant Immunotoxin

Monoclonal Antibody

Pseudomonas Exotoxin

Targeted Therapy

Biologic Therapy

Recruitment Keyword(s):

Non-Hodgkin's Lymphoma

NHL

Condition(s):

Non-Hodgkin's Lymphoma (NHL)

Investigational Drug(s):

CAT 8015 (HA22)

Investigational Device(s):

None

Interventions:

Drug: CAT 8015 (HA22)

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Hennessy BT, Hanrahan EO, Daly PA. Non-Hodgkin lymphoma: an update. Lancet Oncol. 2004 Jun;5(6):341-53. Review.

Salvatore G, Beers R, Margulies I, Kreitman RJ, Pastan I. Improved cytotoxic activity toward cell lines and fresh leukemia cells of a mutant anti-CD22 immunotoxin obtained by antibody phage display. Clin Cancer Res. 2002 Apr;8(4):995-1002.

Kreitman RJ, Squires DR, Stetler-Stevenson M, Noel P, FitzGerald DJ, Wilson WH, Pastan I. Phase I trial of recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) in patients with B-cell malignancies. J Clin Oncol. 2005 Sep 20;23(27):6719-29. Epub 2005 Aug 1.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009