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Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Cancer of the Pancreas That Cannot Be Removed by Surgery

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
motexafin gadolinium
radiation therapy
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed locally advanced, unresectable pancreatic or periampullary adenocarcinoma Patients may have evidence of hepatic or other intra-abdominal or systemic metastases if they have dominant symptomatology from the locally unresectable component of disease Prior treatment with 1 chemotherapy regimen required Palliative bypass procedures without resection allowed Bidimensionally measurable disease on CT or MRI scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hemoglobin at least 8.5 g/dL No history of G6PD deficiency Hepatic: SGOT or SGPT less than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN Bilirubin no greater than 2.0 mg/dL (elevated values must be falling or stable for at least 1 week prior to therapy) Renal: Creatinine no greater than 2.0 mg/dL (no clinical indication of compromised kidney) Other: Not pregnant or nursing Fertile patients must use effective contraception No second malignancy within the past 5 years, except: Resected superficial nonmelanomatous skin cancer Carcinoma in situ of the cervix No uncontrolled or serious medical conditions No active peptic ulcers No weight loss greater than 5% of ideal body weight within 30 days prior to study No uncontrolled nausea and vomiting No claustrophobia PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy No concurrent experimental biologic therapy Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy compromising the delivery of radiation on this study No prior radiotherapy to areas within the planned field of treatment Surgery: At least 4 weeks since prior gastrointestinal surgery Other: At least 4 weeks since prior experimental drugs No other concurrent experimental drugs

Sites / Locations

  • Johns Hopkins Oncology Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
November 13, 2012
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003798
Brief Title
Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Cancer of the Pancreas That Cannot Be Removed by Surgery
Official Title
Phase I Study Involving Gadolinium Texaphyrin (NSC 695238) in Patients With Pancreatic and Periampullary Adenocarcinoma Receiving Radiotherapy for Unresectable Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation therapy in treating patients who have cancer of the pancreas that cannot be removed by surgery.
Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of gadolinium texaphyrin in patients with locally advanced, unresectable pancreatic or periampullary adenocarcinoma undergoing local regional radiotherapy. II. Determine the toxic effects of gadolinium texaphyrin with concurrent radiotherapy in these patients. III. Correlate estimates of tumor and normal organ gadolinium texaphyrin uptake and retention over time by MRI with plasma/serum levels in these patients. OUTLINE: This is a dose escalation study. Patients receive gadolinium texaphyrin IV over 5-10 minutes 4 times weekly at least 2 hours prior to external beam radiotherapy over 2.5 weeks (total of 10 fractions). Cohorts of 3-6 patients are treated at escalating doses of gadolinium texaphyrin. The maximum tolerated dose is defined as the highest dose level in which dose limiting toxicity occurs in no more than 2 of 6 patients. Patients are followed once monthly for 2 months. PROJECTED ACCRUAL: A total of 45 evaluable patients will be accrued for this study within 18-24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
motexafin gadolinium
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced, unresectable pancreatic or periampullary adenocarcinoma Patients may have evidence of hepatic or other intra-abdominal or systemic metastases if they have dominant symptomatology from the locally unresectable component of disease Prior treatment with 1 chemotherapy regimen required Palliative bypass procedures without resection allowed Bidimensionally measurable disease on CT or MRI scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hemoglobin at least 8.5 g/dL No history of G6PD deficiency Hepatic: SGOT or SGPT less than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN Bilirubin no greater than 2.0 mg/dL (elevated values must be falling or stable for at least 1 week prior to therapy) Renal: Creatinine no greater than 2.0 mg/dL (no clinical indication of compromised kidney) Other: Not pregnant or nursing Fertile patients must use effective contraception No second malignancy within the past 5 years, except: Resected superficial nonmelanomatous skin cancer Carcinoma in situ of the cervix No uncontrolled or serious medical conditions No active peptic ulcers No weight loss greater than 5% of ideal body weight within 30 days prior to study No uncontrolled nausea and vomiting No claustrophobia PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy No concurrent experimental biologic therapy Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy compromising the delivery of radiation on this study No prior radiotherapy to areas within the planned field of treatment Surgery: At least 4 weeks since prior gastrointestinal surgery Other: At least 4 weeks since prior experimental drugs No other concurrent experimental drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross A. Abrams, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Cancer of the Pancreas That Cannot Be Removed by Surgery

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