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A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years


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

Thank you

Trial Information

A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years


OBJECTIVES:

Primary

- Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine,
prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's
lymphoma.

- Determine whether the application of the Hasenclever prognostic index is valid in these
patients at diagnosis.

OUTLINE: This is an open-label, multicenter study.

- Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral
procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and
mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the
absence of disease progression or unacceptable toxicity, for a total of 3 courses in
patients with early (stage IA or IIA) disease or 6 courses in patients with advanced
(stage IB or IIB-IV) disease.

- Radiotherapy: Patients with early stage disease receive involved-field radiotherapy.
Patients with advanced stage disease receive radiotherapy limited to sites of initial
bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of
chemotherapy.

Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually
thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed classical Hodgkin's lymphoma

- Previously untreated disease

- No nodular lymphocyte predominant Hodgkin's lymphoma

PATIENT CHARACTERISTICS:

Age

- Over 60

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- No significant hepatic abnormality that would preclude study participation

Renal

- No significant renal abnormality that would preclude study participation

Cardiovascular

- No significant cardiac abnormality that would preclude study participation

Pulmonary

- No significant pulmonary abnormality that would preclude study participation

Other

- "Non-fragile" status (i.e., mental and physical status must be sufficient to
withstand study therapy)

- HIV negative

- No other concurrent neoplasia

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival by routine imaging at 6 month intervals

Safety Issue:

No

Principal Investigator

Stephen J. Proctor, MD, FRCP, FRCPath

Investigator Role:

Study Chair

Investigator Affiliation:

University of Newcastle Upon-Tyne

Authority:

Unspecified

Study ID:

CDR0000354225

NCT ID:

NCT00079105

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

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