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Phase I Study Of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion X 10 Days


Phase 1
18 Years
N/A
Not Enrolling
Both
Cervical Cancer, Fallopian Tube Cancer, Head and Neck Cancer, Lung Cancer, Malignant Mesothelioma, Ovarian Cancer, Pancreatic Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

Phase I Study Of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion X 10 Days


OBJECTIVES:

Primary

- Determine the maximum tolerated dose and toxic effects of SS1(dsFv)-PE38 immunotoxin in
patients with advanced malignancies that express mesothelin.

Secondary

- Determine the response in patients treated with this drug.

- Determine the plasma pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive SS1(dsFv)-PE38 immunotoxin IV continuously on days 1-10. Treatment repeats
every 4 weeks for a maximum of 4 courses in the absence of disease progression or
unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of SS1(dsFv)-PE38 immunotoxin until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignancy, including one of the following:

- Malignant mesothelioma

- Ovarian epithelial carcinoma (mucinous or nonmucinous), including primary
peritoneal or fallopian tube carcinoma

- Tumors that may have originated in the bowel (e.g., appendiceal carcinoma)
and involve the ovary

- Ovarian cancers of other histology are eligible provided they express
mesothelin

- Pancreatic cancer

- Squamous cell lung cancer

- Squamous cell cancer of the head and neck

- Squamous cell cancer of the cervix

- Recurrent unresectable disease after prior standard anticancer therapy that was
expected to prolong survival and improve quality of life OR unwilling to receive
standard anticancer therapy

- At least 30% of initial or recurrent tumor cells positive (at least 1+) for
mesothelin by immunohistochemistry

- Measurable or evaluable disease

- No known CNS or spinal cord involvement

- No clinically significant pericardial effusion

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 75,000/mm^3

Hepatic:

- Bilirubin no greater than upper limit of normal (ULN)

- AST and ALT no greater than 2.5 times ULN

- Albumin at least 3.0 g/dL

- Hepatitis B and C negative

Renal:

- Creatinine no greater than ULN OR

- Creatinine no greater than 2.0 mg/dL if creatinine clearance at least 50 mL/min

- Calcium no greater than ULN

Cardiovascular:

- No New York Heart Association class II-IV heart disease

Pulmonary:

- Oxygen saturation (SO_2) more than 92% on room air

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No detectable antibody to SS1(dsFv)-PE38

- No infection requiring parenteral antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 1 week since prior hematopoietic growth factor therapy

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- At least 4 weeks since any prior antitumor therapy and recovered

- No other concurrent antitumor therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Robert Kreitman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000068351

NCT ID:

NCT00006981

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Fallopian Tube Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Malignant Mesothelioma
  • Ovarian Cancer
  • Pancreatic Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent non-small cell lung cancer
  • stage III cervical cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • stage IVA cervical cancer
  • squamous cell lung cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • ovarian undifferentiated adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • cervical squamous cell carcinoma
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • ovarian carcinosarcoma
  • Brenner tumor
  • untreated metastatic squamous neck cancer with occult primary
  • recurrent salivary gland cancer
  • salivary gland squamous cell carcinoma
  • stage III salivary gland cancer
  • stage IV salivary gland cancer
  • recurrent pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • ovarian mucinous cystadenocarcinoma
  • borderline ovarian surface epithelial-stromal tumor
  • ovarian sarcoma
  • ovarian stromal cancer
  • stage IV pancreatic cancer
  • Uterine Cervical Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Mesothelioma
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182