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Malignant MesotheliomaPhase 1NCT00003263

Cisplatin, Interferon Alfa, Surgery, and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma

A Phase 1 study testing recombinant interferon alfa, cisplatin and surgical procedure in people with Malignant Mesothelioma, run by Fox Chase Cancer Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon alfa may interfere with the growth of cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Mesothelioma
What is being tested?
recombinant interferon alfa, cisplatin and surgical procedure
Type of treatment
Vaccines, Surgery or procedure
How many people
6 participants
Where
3 sitesUnited States
Study dates
Aug 1996to Nov 2000
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically proven ipsilateral malignant pleural mesothelioma
  • No contralateral thoracic or intra-abdominal involvement
  • No distant metastases

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Performance status: ECOG 0 or 1
  • Life expectancy: Not specified
  • Hematopoietic:
  • Absolute neutrophil count greater than 2,000/mm3
  • Platelet count greater than 100,000/mm3
  • No symptomatic anemia requiring transfusion
  • Hepatic:
  • Bilirubin less than 2.0 mg/dL
  • No autoimmune hepatitis
  • No history of decompensated liver disease; e.g. esophageal varices
  • Ascites
  • Albumin at least 2.5 mg/dL
  • Increasing prothrombin time of at least 2.0
  • Renal: Creatinine no greater than 1.5 mg/dL
  • Cardiovascular:
  • No symptomatic or debilitating cardiovascular disease,
  • No concurrent thrombophlebitic or embolic disorders
  • Pulmonary:
  • No symptomatic or debilitating pulmonary disease,
  • Pretreatment diffusion capacity greater than 30% of predicted normal
  • Projected post-treatment FEV1 at least 1.0 L
  • Other:
  • No prior malignancy within 3 years, except nonmelanomatous skin cancer
  • Carcinoma in situ of the cervix
  • Ductal carcinoma in situ of the breast
  • Not pregnant
  • Fertile patients must use effective contraception
  • No history of hypersensitivity to interferon or any component of the injection
  • No uncontrolled diabetes (blood sugars consistently at least 300 mg/dL)
  • No insulin dependent diabetes mellitus with history of ketoacidosis within 1 year
  • No psychosis
  • No uncontrolled thyroid abnormalities
  • No active infection requiring intravenous antibiotics

PRIOR CONCURRENT THERAPY:

  • Biologic therapy: No prior biologic therapy
  • Chemotherapy: No prior chemotherapy
  • Endocrine therapy: Not specified
  • Radiotherapy: No prior radiotherapy
  • Surgery:
  • No prior debulking surgery
  • No prior chest tube drainage with sclerosis if tumor resectable
  • Prior thoracentesis allowed

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Office of S. Terry Kraus

    Marrero, Louisiana, 70072

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: Phase I Combined Modality Protocol for Malignant Mesothelioma: Cisplatin & rIFN-alpha-2b Followed by Surgical Resection (Debulking), and Post-Op Concurrent Chemoradiotherapy With Cisplatin, +/- rIFN-alpha-2b

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy, radiation therapy, and interferon alfa may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of cisplatin plus interferon alfa followed by surgery and interferon alfa plus radiation therapy in treating patients with malignant pleural mesothelioma.

Read the detailed description

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of neoadjuvant interferon alfa 2b (IFN-A2b) administered with cisplatin in patients with malignant pleural mesothelioma. II. Determine the MTD of IFN-A2b administered with radiation therapy and cisplatin after surgery in these patients. III. Determine the response rate and toxicity of induction therapy with IFN-A2b and cisplatin in these patients. IV. Determine the toxicity of concurrent radiation therapy, cisplatin, and IFN-A2b after surgery in these patients. V. Determine the local control rate, freedom from progression, median survival, and long term survival of these patients after combined modality therapy.

OUTLINE: This is a dose escalation study. Patients receive induction therapy consisting of cisplatin IV weekly and interferon alfa 2b (IFN-A2b) subcutaneously three times a week for 6 weeks. Patients who experience at least 25% tumor shrinkage receive another 4 weeks of therapy. Patients then undergo debulking surgery to remove all gross tumor, if possible. If this resection is performed, then patients begin radiation therapy 2-6 weeks after surgery. Patients with unresectable tumors begin radiation therapy 2-4 weeks after the last course of induction chemotherapy. Patients undergo radiation therapy 5 days a week for 6 weeks. Concurrently, patients receive cisplatin IV weekly and IFN-A2b subcutaneously three times a week. Cohorts of 4 patients each receive escalated doses of IFN-A2b during induction chemotherapy. Once the maximum tolerated dose (MTD) of IFN-A2b is established, one dose level below this dose is used for the beginning doses of IFN-A2b during adjuvant chemotherapy. If no unacceptable toxic effects occur, then the dose of IFN-A2b is escalated to the induction MTD. Patients are followed at 3-6 weeks after completing radiochemotherapy, then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2-3 years.

Being tested
recombinant interferon alfa, cisplatin, surgical procedure, radiation therapy
Keywords
localized malignant mesothelioma
Medical subject headings
Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant interferon alfaBiological

    vaccine

  • cisplatinDrug

  • surgical procedureProcedure or surgery

  • radiation therapyRadiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2004 (estimated)
  2. Study startAug 1996
  3. Primary completionDec 1999
  4. Study completionNov 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003263
Sponsor's protocol ID
CDR0000066157
Other IDs
P30CA006927, FCCC-96087, NCI-G98-1401
Status last verified
Apr 2013
First submitted
1 Nov 1999
Last updated
17 Apr 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing recombinant interferon alfa, cisplatin and surgical procedure in people with Malignant Mesothelioma, run by Fox Chase Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013.

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