Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

NCT ID: NCT00276159

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-11-30

Brief Summary

The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.

Detailed Description

852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability

Conditions

Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

852A Treatment

Patients receiving at least one dose of 852A.

Group Type: EXPERIMENTAL

852A

Intervention Type: DRUG

Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.

Interventions

852A

Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.

Intervention Type: DRUG

Other Intervention Names

Molecule 852A; S-32865

Eligibility Criteria

Inclusion Criteria

• Diagnosis of one of the following hematologic malignancies not responding to at least 2 standard treatment regimens. Any criteria for persistent or recurrent disease acceptable, i.e. ≥5% blasts for acute leukemia.

• acute lymphoblastic leukemia (ALL)
• acute myeloid leukemia (AML)
• non-Hodgkin's lymphoma (NHL)
• Hodgkin's lymphoma (HL)
• multiple myeloma (MM)
• chronic lymphocytic leukemia (CLL)
• Performance status - Karnofsky > 50% for patients > 10 years of age or Lansky >50% for patients < 10 year of age
• Normal organ function within 14 days of study entry
• If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation. A female is considered to be of childbearing potential unless she has had her uterus removed, had a double oophorectomy, or has been amenorrheic for at least 6 months after chemotherapy

Exclusion Criteria

• Had/have the following prior/concurrent therapy:

• Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)
• Investigational drugs/agents within 14 days of first dose of 852A
• Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose)
• Drugs known to induce QT interval prolongation and/or induce Torsades De Pointes unless best available drug required to treat life-threatening conditions
• Radiotherapy within 4 weeks of the first dose of 852A
• Hematopoietic cell transplantation 4 weeks of first dose of 852A
• Active infection or fever > 38.5°C within 3 days of first dose of 852A
• Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication
• History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
• Uncontrolled intercurrent or chronic illness
• Active autoimmune disease requiring immunosuppressive therapy within 30 days
• Active hepatitis B or C with evidence of ongoing viral replication
• Hyperthyroidism
• Uncontrolled seizure disorder
• Active coagulation disorder not controlled with medication
• Pregnant or lactating
• Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas adequately treated
• Proven active central nervous system (CNS) disease
• Human Immunodeficiency Virus (HIV) positive
• Congenital long QT syndrome or abnormal baseline QTc interval (> 450 msec in males and > 470 msec in females) after Bazett's correction (QTc msec = QT msec / square root of the RR interval in seconds) on screening electrocardiogram (ECG).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Cooley, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

MT2005-20

Identifier Type: OTHER

Identifier Source: secondary_id

2005LS057

Identifier Type: OTHER

Identifier Source: secondary_id

0509M73467

Identifier Type: OTHER

Identifier Source: secondary_id

05US02IMP-852A

Identifier Type: -

Identifier Source: org_study_id

NCT00326937

Identifier Type: -

Identifier Source: nct_alias