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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Lauren C. Pinter-Brown, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000384961

NCT ID:

NCT00091208

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781