Clinical trial · Interventional

Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Colon Cancer That Has Not Responded to Vaccine Therapy

A Pilot Study of Ipilimumab (MDX-CTLA4, MDX-010) in Lymphoma

NCT00047164CI-TRIAL-00024035completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Monoclonal antibodies such as anti-cytotoxic T-lymphocyte-associated antigen-4 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: This phase II trial is studying anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody to see how well it works in treating patients with lymphoma or colon cancer that has not responded to vaccine therapy.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
ipilimumab	Biological	Ipilimumab	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Toxicity after every 3 courses of treatment and every month for up to a year after completion of study treatment

Secondary outcomes (1)

measure
T-cell response after every 3 courses of treatment and every month for up to a year after completion of study treatment

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed prostate cancer (closed to accrual as of 3/9/2005)

  * Prior therapy on protocol NCI-00-C-0137 or NCI-00-C-0154
  * Progressive disease (2 consecutively rising PSA levels, new bone scan lesion, or progression of soft tissue)
  * PSA at least 5 ng/mL
  * Progressive androgen-independent disease

    * Disease progression at least 4 weeks after flutamide withdrawal OR
    * Disease progression at least 6 weeks after bicalutamide or nilutamide withdrawal OR
* Histologically confirmed follicular or mantle cell non-Hodgkin's lymphoma (mantle cell lymphoma closed to accrual as of 3/9/2005)

  * Prior therapy on protocol NCI-00-C-0133, NCI-01-C-0169, or NCI-00-C-0050
  * Progressive disease after standard treatment
  * Relapsed disease OR
* Histologically confirmed colon cancer (colon cancer closed to accrual as of 9/28/05)

  * Prior therapy on protocol NCI-99-C-0023
  * Progressive disease OR
* Histologically confirmed non-Hodgkin's lymphoma or Hodgkin's lymphoma

  * Progressive disease after standard treatment
  * No curative therapy exists
  * Prior allogeneic stem cell transplantation from a matched sibling or matched unrelated donor for an aggressive lymphoma allowed

    * Last infusion of allogeneic cells (either hematopoietic stem cells or donor lymphocytes) must have occurred \> 90 days prior to study enrollment
* No other standard therapy available or refused such therapy
* No symptomatic or rapidly progressive malignancy requiring therapy
* No symptomatic CNS metastases

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 80-100%

Life expectancy

* More than 2 months

Hematopoietic

* WBC at least 2,500/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 50,000/mm\^3
* Hemoglobin at least 10 g/dL
* Hematocrit at least 30%

Hepatic

* Bilirubin no greater than 3.0 mg/dL (unless due to Gilbert's disease)
* SGOT and SGPT no greater than 3 times upper limit of normal
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative

Renal

* Creatinine no greater than 2.0 mg/dL

Immunologic

* HIV negative
* Rheumatoid factor negative if history or evidence of arthritis
* Anti-nuclear antibody (ANA) titer no greater than 1:80 if history or clinical signs or symptoms of connective tissue disease
* No prior or active autoimmune disease (e.g., uveitis, rheumatoid arthritis, lupus erythematosus, autoimmune hemolytic anemia, ulcerative and hemorrhagic colitis, endocrine disorders \[e.g., thyroiditis, hyperthyroidism, hypothyroidism, autoimmune hypophysitis/hypopituitarism, or adrenal insufficiency\], sarcoid granuloma, myasthenia gravis, polymyositis,or Guillain-Barre syndrome)
* No positive antibody titers to autoimmune diseases

  * Rheumatoid factor positive allowed unless ANA titer is greater than 1:80 and there is a history of or clinical signs or symptoms of connective tissue disease
* No active infection

Other

* No other active malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics
* Recovered from prior vaccine therapy
* No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) for patients in part I of study

  * Patients in part II of study may have had up to 4 prior treatments with MDX-CTLA4
* No concurrent vaccine therapy
* No concurrent infliximab

Chemotherapy

* At least 4 weeks since prior cytotoxic chemotherapy
* No concurrent mercaptopurine, methotrexate, or cyclophosphamide

Endocrine therapy

* See Disease Characteristics
* At least 4 weeks since prior steroids
* No concurrent systemic, inhaled, or topical steroids

Radiotherapy

* At least 4 weeks since prior radiotherapy

Surgery

* At least 4 weeks since prior major surgery

Other

* Prior intervening therapy for prostate cancer, non-Hodgkin's lymphoma or colon cancer allowed
* No other concurrent investigational therapy
* No other concurrent immunosuppressants (e.g., cyclosporine or its analog)

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment