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Phase II Trial Of Campath-1H In Patients With Relapsed/Refractory Advanced Mycosis Fungoides or Sezary Syndrome


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

Thank you

Trial Information

Phase II Trial Of Campath-1H In Patients With Relapsed/Refractory Advanced Mycosis Fungoides or Sezary Syndrome


OBJECTIVES:

- Determine the response rate of patients with relapsed or recurrent advanced mycosis
fungoides or Sézary syndrome treated with alemtuzumab.

- Determine the toxicity of this drug in these patients.

OUTLINE: Patients receive alemtuzumab IV over 2 hours three times per week. Treatment
continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed mycosis fungoides or Sézary syndrome

- Stage IB-IVB

- Measurable disease

- One or more indicator lesions

- No prior radiotherapy to areas of measurable disease unless there is clear
disease progression at the site or measurable disease outside the area of prior
radiotherapy

- Generalized erythrodermia patients with evaluable disease only are allowed

- Must have failed at least 1 prior systemic therapy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 OR

- WHO 0-2

Life expectancy

- At least 3 months

Hematopoietic

- WBC at least 3,000/mm^3

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 2.2 mg/dL

- AST or ALT no greater than 2 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2 times ULN

Renal

- Creatinine no greater than 2.0 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No acute infection requiring intravenous antibiotics

- No other prior neoplasm except treated squamous cell or basal cell skin cancer,
treated carcinoma in situ of the cervix, or other cancer that received surgical
treatment only from which patient has been disease free for at least 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior biologic therapy

Chemotherapy

- More than 4 weeks since prior chemotherapy

Endocrine therapy

- More than 4 weeks since prior topical steroids

Radiotherapy

- See Disease Characteristics

- At least 2 weeks since prior radiotherapy (local control or palliative)

- No concurrent radiotherapy to any lesion

Surgery

- Recovered from prior major surgery

Other

- Recovered from prior therapy

- No other concurrent proven or investigational antineoplastic agents

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome

Outcome Description:

Response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome will be assessed by medical photograph (skin lesion) measurements or by CT scan for internal lesions upon study entry, weekly while on study, then once when patient goes off study

Outcome Time Frame:

At baseline, weekly while on treatment, then once when patient goes off study

Safety Issue:

No

Principal Investigator

Timothy M. Kuzel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Federal Government

Study ID:

NU 99H8

NCT ID:

NCT00057967

Start Date:

July 2000

Completion Date:

August 2014

Related Keywords:

  • 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
  • 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
  • Lymphoma
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome

Name

Location

Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Northwestern University, Northwestern Medical Faculty FoundationChicago, Illinois  60611-3013