Study of Repeat Intranodal Injection of Memgen's Cancer Vaccine, Ad-ISF35, in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

NCT00849524 | Terminated Phase 2 Results DMC

• 2 other identifiers: UCSD-101357 - prev 080497CLL-35-202
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II, open label, fixed dose, repeat injection, single institution study. Eligible subjects will receive up to six doses of Ad-ISF35 injected directly into a selected lymph node under ultrasound guidance. The primary goal is to determine and monitor clinical and biological responses in patients treated with repeat intranodal injections of Ad-ISF35.

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

• Determine and Monitor Clinical and Biological Responses in Patients Treated With Repeat Intranodal Injections of Ad-ISF35.

  2 years (evaluation will be approx. 4 months per patient)

Secondary Outcomes (2)

• Determine the Safety of Repeat Administration of Ad-ISF35 Injected Directly Into Lymph Nodes of Patients With CLL/SLL.

  2 years (evaluation will be approx. 1 year per patient)

• Determine Pharmacodynamic Parameters in Patients Treated With Repeat Intranodal Injections of Ad-ISF35.

  2 years (evaluation will be approx. 4 months per patient)

Study Arms (1)

Ad-ISF35

EXPERIMENTAL

Ad-ISF35, intranodal injection, 3.3 x 10\^10 ISF35 viral particles, every 2-4 weeks up to six total injections.

Biological: ISF35

Interventions

ISF35 BIOLOGICAL

Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10\^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.

Ad-ISF35

Eligibility Criteria

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

You may qualify if:

• Diagnosis of B-cell CLL/SLL including:
• Lymphocytosis of monoclonal B-cells co-expressing ≥ one B-cell marker (CD19, CD20, or CD23) AND
• CD5 in peripheral blood or lymph node AND
• Bone marrow with ≥ 30% mononuclear cells having the CLL/SLL phenotype.
• Presence of at least ONE single accessible AND palpable lymph node in the cervical, supraclavicular, axillary, or inguinal regions. The size of the lymph nodes must be larger than 2x2 cm in the horizontal and perpendicular axes.
• Intermediate or High risk, poor prognosis CLL/SLL
• Indication for treatment as defined by the NCI Working Group Guidelines:
• Massive (\> 6 cm below the left costal margin) or progressive splenomegaly OR
• Massive lymph nodes or nodal clusters (\> 10 cm in longest diameter) OR \*Progressive lymphadenopathy OR
• Grade 2 or 3 fatigue OR
• Fever ≥ 100.5 degrees F OR
• Night sweats for greater than 2 weeks without documented infection OR
• Presence of weight loss ≥ 10% over the preceding 6 months OR
• Progressive lymphocytosis with an increase of ≥ 50% over a 2-month period OR
• An anticipated doubling time of less than 6 months.

You may not qualify if:

• Pregnant or nursing women.
• Treatment with chemotherapy or monoclonal antibody within 28 days prior to entering the study.
• Treatment with chemotherapy or monoclonal antibody during the time of participation in this trial.
• Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
• Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD).
• Participation in any investigational drug study within 28 days prior to ISF35 administration. (Patient must have recovered from all acute effects of previously administered investigational agents)
• History of malignancy other than CLL within five years of registration, except patients with adequately treated basal, squamous cell carcinoma or localized cervical cancer.
• Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis.
• Any illness or condition that in the opinion of the Investigator may affect safety of treatment or evaluation of any the study's endpoints.

Sponsors & Collaborators

• Januario Castro, M.D.: lead
• FDA Office of Orphan Products Development: collaborator
• Memgen, LLC: collaborator

Study Sites (1)

University of California, San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Januario Castro, MD
• Organization: University of California, San Diego

jecastro@ucsd.edu

(858) 822-6600

Study Officials

• Januario Castro, M.D.

  Associate Clinical Professor in the Blood and Marrow Transplantation Division

  PRINCIPAL INVESTIGATOR

• Thomas J Kipps, M.D., Ph.D.

  Professor of Medicine, Evelyn and Edwin Tasch Chair in Cancer Research in the UCSD School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 24, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2014
• Last Updated: December 30, 2015
• Results First Posted: November 20, 2015

Record last verified: 2015-11

Locations

US (1)