Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
CpG 7909 in Treating Patients With Cutaneous T-Cell Lymphoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00091208
  Purpose

RATIONALE: Biological therapies, such as CpG 7909, use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: This randomized phase I/II trial is studying the side effects of CpG 7909 and to see how well it works in treating patients with cutaneous T-cell lymphoma.


Condition Intervention Phase
Lymphoma
Drug: agatolimod sodium
Phase I
Phase II

MedlinePlus related topics: Cancer Fungal Infections Lymphoma
Drug Information available for: Agatolimod sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A Phase I/II Open Label, Multi-Center Study For The Evaluation Of CPG 7909 In Patients With Stage IB To IVA Cutaneous T-Cell Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response rate (complete clinical response [CCR] and partial response [PR]) as measured by the Composite Assessment of Index Lesion Disease Severity [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response as measured by the Physician Global Assessment of Clinical Condition criteria [ Designated as safety issue: No ]
  • Duration of overall response (CCR and PR) [ Designated as safety issue: No ]
  • Duration of CCR [ Designated as safety issue: No ]
  • Duration of PR [ Designated as safety issue: No ]
  • Time to response [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]

Study Start Date: July 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety of CpG 7909, in terms of adverse events, vital signs, and laboratory and clinical findings, in patients with stage IB-IVA cutaneous T-cell lymphoma.
  • Determine tumor response, as measured by the Composite Assessment of Index Lesion Disease Severity (CA), in patients treated with this drug.
  • Determine the tolerability of this drug in these patients.
  • Determine the immunopharmacodynamics of this drug in these patients.

Secondary

  • Determine disease response, based on the Physician Global Assessment of Clinical Condition (PGA), in patients treated with this drug.
  • Determine duration of response, based on the CA and PGA, in patients treated with this drug.
  • Determine time to response in patients treated with this drug.
  • Determine time to progression in patients treated with this drug.

OUTLINE: This is a phase I, open-label, multicenter, dose-escalation study followed by a randomized phase II study.

  • Phase I: Patients receive CpG 7909 subcutaneously (SC) once weekly on weeks 1-24 in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CpG 7909 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients are randomized to receive 1 of 2 doses of CpG 7909, administered as in phase I.

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: A total of 3-56 patients (3-36 for phase I and 20 [10 per treatment arm] for phase II) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed cutaneous T-cell lymphoma (CTCL) (limited to mycosis fungoides)

    • Stage IB-IVA disease
    • No other cutaneous lymphomas including, but not limited to, CD30-positive large-cell T-cell lymphoma, lymphomatoid papulosis, and pagetoid reticulosis
    • No visceral disease (stage IVB CTCL)
  • Must have received 1-3 prior systemic regimen(s), including psoralen ultraviolet light therapy (PUVA)
  • No CNS disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 4 months

Hematopoietic

  • Neutrophil count ≥ 1,000/mm^3
  • Platelet count > 100,000/mm^3
  • WBC > 4,000/mm^3
  • Hemoglobin ≥ 10 g/dL

Hepatic

  • Bilirubin ≤ 1.5 mg/dL
  • SGOT or SGPT < 3 times upper limit of normal
  • PTT ≤ 40 seconds
  • No active hepatitis B or C

Renal

  • Creatinine ≤ 2.0 mg/dL

Cardiovascular

  • No unstable angina
  • No New York Heart Association class III-IV congestive heart failure
  • No myocardial infarction within the past 6 months
  • No uncontrolled atrial or ventricular cardiac arrhythmias
  • No other significant cardiovascular disease

Immunologic

  • HIV negative
  • No autoimmune or antibody-mediated disease, including any of the following:

    • Systemic lupus erythematosus
    • Rheumatoid arthritis
    • Multiple sclerosis
    • Sjögren's syndrome
    • Autoimmune thrombocytopenia
  • Controlled thyroid disease allowed
  • Autoantibodies without clinical autoimmune disease allowed
  • No history of allergic reactions attributed to compounds of similar composition to CpG 7909
  • No fever ≥ 38.2°C within the past 24 hours
  • No serious, symptomatic, significant local or systemic infection, including urinary tract infection

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • No suspected or confirmed poor compliance, mental instability, or prior or current alcohol or drug abuse that would preclude study participation or giving informed consent
  • No other medical history, including laboratory results, that would preclude study participation
  • No other malignancy within the past 5 years except basal cell or completely excised non-invasive squamous cell skin cancer or squamous cell carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent denileukin diftitox
  • No other concurrent immunotherapy, including but not limited to, interleukin-2, interferon (IFN) alfa, or IFN gamma

Chemotherapy

  • At least 4 weeks since prior systemic chemotherapy for CTCL
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent topical or systemic corticosteroids

Radiotherapy

  • At least 4 weeks since prior electron beam therapy for CTCL
  • No concurrent radiotherapy

Surgery

  • More than 6 months since prior coronary angioplasty

Other

  • At least 2 weeks since prior topical therapy for CTCL
  • At least 3 weeks since prior phototherapy for CTCL
  • At least 4 weeks since prior photopheresis for CTCL
  • At least 4 weeks since other prior systemic therapy for CTCL
  • At least 4 weeks since prior daily systemic cholecalciferol (vitamin D) > 15,000 IU for CTCL
  • At least 4 weeks since prior oral retinoids, including bexarotene for CTCL
  • At least 4 weeks since prior investigational therapy for CTCL
  • No prior treatment for hepatitis B or C
  • More than 2 weeks since prior systemic antibiotics for CTCL

    • Patients receiving systemic antibiotics for CTCL must be on a stable regimen for at least 2 weeks before study entry
  • More than 30 days since prior participation in an investigational drug trial
  • No concurrent chloroquine phosphatase
  • No concurrent anticoagulant therapy except aspirin (≤ 325 mg/day)
  • No concurrent phototherapy
  • No concurrent photopheresis therapy
  • No concurrent bexarotene
  • No concurrent immunosuppressants
  • No other concurrent investigational drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091208

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Lauren C. Pinter-Brown, MD Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000384961, UCLA-030104201A, CPGI-C014, CPGI-CPG7909-C014
Study First Received: September 7, 2004
Last Updated: December 6, 2008
ClinicalTrials.gov Identifier: NCT00091208  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent mycosis fungoides/Sezary syndrome
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome

Study placed in the following topic categories:
Sezary syndrome
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Lymphoma, small cleaved-cell, diffuse
Sezary Syndrome
Mycosis Fungoides
Recurrence
Mycoses
Lymphatic Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009