MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
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| ClinicalTrials.gov Identifier: NCT00112580 |
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Recruitment Status :
Completed
First Posted : June 3, 2005
Results First Posted : September 27, 2021
Last Update Posted : September 27, 2021
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RATIONALE: Biological therapies, such as MDX-010, may stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase II trial is studying how well MDX-010 works in treating patients with stage IV pancreatic cancer that cannot be removed by surgery.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Cancer | Biological: ipilimumab | Phase 2 |
OBJECTIVES:
Primary
- Determine clinical response (partial and complete responses) in patients with unresectable stage IV (locally or distantly metastatic) pancreatic adenocarcinoma treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010).
Secondary
- Determine whether observed responses correlate with the incidence of autoimmunity in patients treated with this drug.
OUTLINE: This is an open-label study. Patients are stratified according to status of disease (locally vs distantly metastatic).
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on days 0, 21, 42, and 63. Treatment repeats every 84 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression after achieving a partial response or complete response receive 2 additional courses of therapy.
After completion of study treatment, patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 42-82 patients (21-41 per stratum) will be accrued for this study within 2-4 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 27 participants |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma |
| Actual Study Start Date : | July 31, 2005 |
| Actual Primary Completion Date : | June 30, 2009 |
| Actual Study Completion Date : | June 30, 2009 |
- Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [ Time Frame: From first dose to 3 weeks following the end of the treatment cycle, up to 24 weeks. ]Percentage of participants who achieved Complete Response (CR) or Partial Response (PR) according to RECIST criteria. Particularly, CR is defined as disappearance of all target lesions, while PR is defined as at least a 30% decrease n the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed pancreatic adenocarcinoma
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Stage IV disease
- Locally (invasion of adjacent structures, including mesenteric arteries or organs) or distantly metastatic disease
- Unresectable disease
- Pancreatic adenocarcinoma with intraductal papillary mucinous neoplasm allowed
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The following diagnoses are not allowed:
- Acinar cell carcinoma
- Pancreaticoblastoma
- Malignant cystic neoplasms
- Endocrine neoplasms
- Squamous cell carcinoma
- Vater and periampullary duodenal or common bile duct malignancies
- Clinically evaluable disease with ≥ 1 site of measurable disease
- Biliary or gastric outlet obstruction allowed provided it is effectively drained by endoscopic, operative, or interventional means
- Pancreatic, biliary, or enteric fistulae allowed provided they are controlled with an appropriate drain
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- WBC ≥ 2,500/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Hematocrit ≥ 27%
Hepatic
- Hepatitis B surface antigen negative
- Hepatitis C virus antibody negative OR
- Hepatitis C RNA negative by polymerase chain reaction
Renal
- Creatinine < 2.0 mg/dL
Immunologic
- HIV negative
- No history of or active autoimmune disease, including uveitis or autoimmune inflammatory eye disease
- No active uncontrolled infection
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- No underlying medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010)
Chemotherapy
- At least 3 weeks since prior chemotherapy for pancreatic adenocarcinoma and recovered
- No concurrent chemotherapy
Endocrine therapy
- More than 4 weeks since prior corticosteroids
- No concurrent systemic or topical corticosteroids
Radiotherapy
- At least 3 weeks since prior radiotherapy for pancreatic adenocarcinoma and recovered
Surgery
- See Disease Characteristics
Other
- At least 3 weeks since other prior therapy for pancreatic adenocarcinoma and recovered
- No concurrent immunosuppressants (e.g., cyclosporin or its analog)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112580
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| NCI - Surgery Branch | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Documents provided by Bristol-Myers Squibb:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00112580 |
| Obsolete Identifiers: | NCT00108888 |
| Other Study ID Numbers: |
CDR0000430666 NCI-05-C-0141 NCI-P6557 MDX-010-24 |
| First Posted: | June 3, 2005 Key Record Dates |
| Results First Posted: | September 27, 2021 |
| Last Update Posted: | September 27, 2021 |
| Last Verified: | September 2021 |
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recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases |
Endocrine System Diseases Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |