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A Phase I Study Of G3139 Antisense Oligonucleotide (Oblimersen) In Combination With CHOP And Rituximab In Untreated Advanced Stage Diffuse Large B Cell Lymphoma

Phase 1
19 Years
Not Enrolling

Thank you

Trial Information

A Phase I Study Of G3139 Antisense Oligonucleotide (Oblimersen) In Combination With CHOP And Rituximab In Untreated Advanced Stage Diffuse Large B Cell Lymphoma



- Determine the feasibility and safety of oblimersen administered in combination with
rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, in terms of
short-term and long-term toxicity, in patients with previously untreated stage III or
IV or extensive or bulky stage II diffuse large B-cell lymphoma.

- Determine the maximum tolerated dose of oblimersen administered with this regimen in
these patients.


- Determine the remission rate and failure-free, progression-free, and overall survival
of patients treated with this regimen.

OUTLINE: This is a nonrandomized, non-blinded, multicenter, dose-escalation study of

Patients receive CHOP-R* therapy comprising cyclophosphamide IV over 15-45 minutes,
doxorubicin IV over 5-10 minutes, vincristine IV, and rituximab IV over 30-90 minutes on day
1 and oral prednisone on days 1-5. Patients also receive oblimersen IV continuously on days
-4 to 3. Treatment repeats every 21 days for 6-8 courses in the absence of disease
progression or unacceptable toxicity. Patients who discontinue treatment due to unacceptable
toxicity to oblimersen may continue to receive standard therapy comprising CHOP-R.

NOTE: *Patients treated at the British Columbia Cancer Agency receive cyclophosphamide,
doxorubicin, vincristine, and rituximab on days 1 and 2 and prednisone as above.

Cohorts of 3-6 patients receive escalating doses of oblimersen 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. Once the MTD is determined, at least 10
patients are treated at that dose level.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months
for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-28 patients will be accrued for this study within 5-10

Inclusion Criteria


- Histologically confirmed* CD20+ diffuse large B-cell lymphoma, including any of the
following stages:

- Extensive stage II (not radio-encompassable within a single involved field or
not a candidate for brief chemotherapy and radiotherapy)

- Bulky stage II (any single mass greater than 10 cm)

- Stage III

- Stage IV NOTE: *Confirmed by tissue biopsy

- Previously untreated disease

- Measurable disease

- At least 2 cm by imaging studies

- Circulating lymphoma cells no greater than 5,000/mm^3

- No history of other lymphoproliferative disorder

- No history of indolent lymphoma

- No T-cell lymphoma

- No CNS involvement

- No post-transplantation lymphoproliferative disorder



- 19 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count at least 1,500/mm^3 (unless due to bone marrow involvement
with lymphoma)

- Platelet count at least 100,000/mm^3 (unless due to splenomegaly or bone marrow
involvement with lymphoma)


- Bilirubin no greater than 3 mg/dL (unless due to lymphoma)

- No known hepatitis B virus


- Creatinine no greater than 2 mg/dL (unless due to lymphoma)


- No cardiac contraindication to doxorubicin therapy (e.g., abnormal contractility on

- History of cardiac disease allowed provided ejection fraction is normal


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Adequate venous access

- HIV negative

- No other malignancy within the past 5 years except adequately treated nonmelanoma
skin cancer, localized basal cell or squamous cell skin cancer, or curatively treated
carcinoma in situ of the cervix

- No neurological contraindication to vincristine (e.g., peripheral neuropathy)

- No active systemic infection

- No medical condition that would compromise study treatment, add toxicity, or impair


Biologic therapy

- Not specified


- No prior systemic chemotherapy

Endocrine therapy

- Not specified


- No prior radiotherapy

- Prior radiotherapy for localized basal cell or squamous cell skin cancer used
with curative intent allowed


- Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard J. Klasa, MD

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency


United States: Federal Government

Study ID:




Start Date:

July 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse



Stanford Cancer Center at Stanford University Medical Center Stanford, California  94305