SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma

Summary

Background:

* Malignant mesothelioma is a form of cancer that develops on the protective lining that covers the body's internal organs. It most often occurs on the lining of the lungs and chest wall or the lining of the abdomen. There is no known cure for malignant mesothelioma, so researchers are searching for new ways to treat it.
* Mesothelin is a protein that is found in mesothelioma and other types of cancer cells. An experimental cancer drug called SS1P is designed to attack cells that have mesothelin while leaving healthy cells alone. Researchers want to test how effective SS1P is when it is given with pentostatin and cyclophosphamide. These drugs help suppress the immune system and may make the SS1P more effective.

Objectives:

\- To study the effectiveness of SS1P plus two drugs that suppress the immune system to treat malignant mesothelioma.

Eligibility:

\- Individuals at least 18 years of age who have malignant mesothelioma in the chest or abdomen.

Design:

* Participants will be screened with a physical exam, medical history, and blood tests. They will also have imaging studies.
* The first treatment cycle will last 30 days. Up to three 21-day cycles of treatment will follow.
* In the first cycle, participants will have pentostatin on days 1, 5, and 9. They will have cyclophosphamide on days 1 through 12. They will have SS1P on days 10, 12, and 14.
* On the next three cycles, participants will have pentostatin on day 1.They will have cyclophosphamide on days 1 through 4. They will have SS1P on days 2, 4, and 6.
* Participants will have frequent blood tests and other studies. They will receive all four cycles of treatment as long as there are no severe side effects.
* Participants will have regular followup visits as directed by the study doctors.

Conditions

• Mesothelioma
• Adenocarcinoma of Lung
• Pancreatic Neoplasms

Interventions

DRUG

Pentostatin

Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle

DRUG

Cyclophosphamide

Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle

BIOLOGICAL

SS1(dsFv)PE38 - lot 073I0809

Regimen A: Cycle 1: Cycle 1: 35mcg/kg days 10, 12 and 14 Cycles 2-4: Days 2, 4 and 6, for a maximum of six treatment cycles Regimen B: Cycle 1: 35mcg/kg days 18, 20 and 22 Cycles 2-4: (Days 6, 8 and 10), for a maximum of six treatment cycles

BIOLOGICAL

SS1(dsFv)PE38 - lot FIL129J01

Regimen A: Cycle 1: Cycle 1:35mcg/kg or 25 mcg/kg days 10, 12 and 14 Cycles 2-4: Days 2, 4 and 6, for a maximum of six treatment cycles

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Raffit Hassan, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-11

Primary Completion

2016-08-03

Completion

2017-08-07

FDA Drug

Yes

Countries

• United States

Study Locations