Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

CpG 7909 in Treating Patients With Cutaneous T-Cell Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	UCLA-030104201A CPGI-C014, CPGI-CPG7909-C014, NCT00091208

Objectives

Primary

1. 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.
2. Determine tumor response, as measured by the Composite Assessment of Index Lesion Disease Severity (CA), in patients treated with this drug.
3. Determine the tolerability of this drug in these patients.
4. Determine the immunopharmacodynamics of this drug in these patients.

Secondary

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

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 4 months

Hematopoietic

• Neutrophil count ≥ 1,000/mm³
• Platelet count > 100,000/mm³
• WBC > 4,000/mm³
• 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

Expected Enrollment

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.

Outcomes

Tumor response rate (complete clinical response [CCR] and partial response [PR]) as measured by the Composite Assessment of Index Lesion Disease Severity

Tumor response as measured by the Physician Global Assessment of Clinical Condition criteria
Duration of overall response (CCR and PR)
Duration of CCR
Duration of PR
Time to response
Time to disease progression

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Lauren Pinter-Brown, MD, Protocol chair		Ph: 310-206-7023; 888-798-0719 Email: lpb@ucla.edu

Registry Information
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
Trial Start Date		2004-07-30
Registered in ClinicalTrials.gov		NCT00091208
Date Submitted to PDQ		2004-07-30
Information Last Verified		2006-04-11
NCI Grant/Contract Number		CA16042