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A Phase II Study Of Gemcitabine, Dexamethasone, And Cisplatin (GDP) In Patients With Either Hodgkin's Disease Or Aggressive Histology Non-Hodgkin's Lymphoma Which Is Relapsed Or Refractory


Phase 2
16 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Study Of Gemcitabine, Dexamethasone, And Cisplatin (GDP) In Patients With Either Hodgkin's Disease Or Aggressive Histology Non-Hodgkin's Lymphoma Which Is Relapsed Or Refractory


OBJECTIVES:

- Determine the efficacy of gemcitabine, dexamethasone, and cisplatin in patients with
relapsed or refractory Hodgkin's disease or aggressive non-Hodgkin's lymphoma.

- Determine the qualitative and quantitative toxicity of this regimen in these two
patient populations.

OUTLINE: This is a multicenter study. Patients are stratified according to disease
(Hodgkin's disease vs non-Hodgkin's lymphoma).

Patients receive oral dexamethasone on days 1-4, cisplatin IV over 1 hour on day 1, and
gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6
courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, 3 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 44-88 patients (22-44 per stratum) will be accrued for this
study within 4-10 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed Hodgkin's disease OR

- Histologically or cytologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of
B-cell origin (including immunoblastic, anaplastic large cell, mediastinal large
B-cell, or T-cell rich B-cell NHL)

- No prior diagnosis of low-grade NHL

- No histologic evidence of transformation from indolent to aggressive histology

- Bidimensionally measurable disease that is clinically or radiologically documented

- Bone lesions not considered bidimensionally measurable

- Lymph nodes at least 1.5 cm by 1.5 cm OR

- Other non-nodal lesions at least 1 cm by 1 cm

- Recurrent or refractory to 1 prior chemotherapy regimen (excluding gemcitabine and
cisplatin)

- No known CNS involvement NOTE: A new classification scheme for adult non-Hodgkin's
lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive"
lymphoma will replace the former terminology of "low", "intermediate", or "high"
grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

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

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

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST or ALT no greater than 2.5 times ULN

Renal:

- Creatinine less than 1.6 mg/dL

Cardiovascular:

- No significant cardiac dysfunction or cardiovascular disease

Other:

- HIV negative

- No other concurrent or prior malignancy within the past 5 years except adequately
treated basal cell carcinoma of the skin or carcinoma in situ of the cervix

- No other serious illness or medical condition that would preclude study

- No active uncontrolled bacterial, fungal, or viral infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior stem cell transplantation

- No concurrent monoclonal antibody therapy

- No concurrent growth factors during the first course of study

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior IV chemotherapy

- No prior cisplatin or gemcitabine

- No prior high-dose chemotherapy

- No other concurrent cytotoxic therapy

Endocrine therapy:

- No concurrent corticosteroids, except for physiologic replacement

Radiotherapy:

- No prior radiotherapy to more than 25% of functioning bone marrow

- At least 4 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

Surgery:

- At least 2 weeks since prior major surgery

Other:

- No other concurrent anti-cancer therapy or experimental therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael R. Crump, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

United States: Federal Government

Study ID:

LY10

NCT ID:

NCT00014209

Start Date:

December 2000

Completion Date:

February 2009

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • anaplastic large cell lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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