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Chronic Lymphocytic LeukemiaPhase 2NCT00849524

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

A Phase 2 study testing ISF35 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Januario Castro, M.D. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ISF35
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Jan 2009to Jul 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia.
  • Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy.
  • Males and females 18 years of age and older
  • Laboratory parameters as specified below:
  • Hematologic: Hemoglobin ≥ 10 g/dL (may be post-transfusion); platelet count ≥ 50x10^3/mm^3
  • Hepatic: Total Bilirubin < 2 x ULN, and ALT and AST < 2 x ULN
  • Renal: Creatinine ≤ 2 x ULN
  • ECOG Performance Status ≤ 2
  • Anticipated survival of at least 3 months
  • For men and women of child-producing potential, use of effective barrier contraceptive methods during the study and for one month following treatment.
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
  • Negative test results for current/active infection with HIV-1, HIV-2, HTLV-1, HTLV-2, CMV, hepatitis A, B, C within 30 days of registration. (Antibody, antigen and nucleic acid tests acceptable, depending on institutional standards.).
  • Subjects must give written informed consent to participate in this trial.
  • Subjects must have received treatment for CLL with chemotherapy agents or antibodies OR if subjects are previously untreated they must state in the consent form that they are refusing to be treated with chemotherapy or antibodies.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Diego Moores Cancer Center

    La Jolla, California, 92093

Other trials in United States

About this study

Official title: A Phase II Study of Repeat Intranodal Injections of Adenovirus-CD 154 (Ad-ISF35) in Patients With Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma

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.

Read the detailed description

This is a phase II clinical trial in which study subjects 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.

Because this is the first time that repeat administration of Ad-ISF35 will be performed via intranodal injection, and in order to allow sufficient time to evaluate the safety and toxicity of this procedure, we will treat subjects 1 thru 3 at one month intervals and with inpatient admission for 24 hours observation. After subject three receives their second ISF35 injection we will proceed with enrollment of cohorts of four patients per month at one week intervals until study enrollment has been completed. These subjects will be treated as outpatients and will be observed for 3 hours prior to discharge.

ISF35 has already been used in Phase I clinical trials. The trials demonstrated that ISF35 treatment is well-tolerated and patients did not experience any significant or unexpected adverse events. Patients reported flu-like symptoms from ISF35, which disappeared within one to three days.

ISF35 is an abbreviation for Immune Stimulatory Factor 35, an offspring of technology discovered by Dr. Thomas J. Kipps, MD, PhD, Professor, Department of Medicine and Deputy Director for Research,UCSD Moores Cancer Center.

Being tested
ISF35
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ISF35Biological

    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.

Study groups in NCT00849524
Study groupRoleWhat they receive
Ad-ISF35ExperimentalAd-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
Receives: Biological: ISF35

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (2)

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionJul 2009
  4. Study completionJul 2014

Why it stopped: drug supply became unavailable

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00849524
Sponsor's protocol ID
UCSD-101357 - prev 080497
Other IDs
CLL-35-202
Status last verified
Nov 2015
First submitted
20 Feb 2009
Last updated
30 Dec 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ISF35 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Januario Castro, M.D. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine and Monitor Clinical and Biological Responses in Patients Treated With Repeat Intranodal Injections of Ad-ISF35. (time frame: 2 years (evaluation will be approx. 4 months per patient)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00849524.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.

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