Clinical trial · Interventional

Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors

Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing

NCT00066651CI-TRIAL-00017731completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating advanced solid tumors. PURPOSE: This phase I trial is studying the side effects and best dose of immunotoxin therapy in treating patients with recurrent unresectable advanced solid tumors.

Conditions

Conditions (8)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cervical Cancer	Malignant Cervical Neoplasm	CURATED_EXACT	0.92
Fallopian Tube Cancer	Malignant Fallopian Tube Neoplasm	ALIAS	0.90
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Malignant Mesothelioma	Malignant Mesothelioma	ONTOLOGY_EXACT	0.98
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.92
Primary Peritoneal Cavity Cancer	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
SS1(dsFv)-PE38 immunotoxin	Biological	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed advanced malignancy of 1 of the following types:

  * Ovarian cancer

    * All nonmucinous epithelial histologies are eligible
  * Primary peritoneal cavity cancer
  * Fallopian tube cancer
  * Malignant mesothelioma

    * No sarcomatous histology
  * Pancreatic cancer
  * Squamous cell cancer (SCC) of the lung
  * SCC of the cervix
  * SCC of the head and neck
* Recurrent unresectable disease, meeting 1 of the following criteria:

  * Previously treated with definitive standard therapy
  * Patient refused prior standard therapy
* Initial or recurrent tumor positive (at least 30% of tumor cells) for mesothelin by immunohistochemistry\* NOTE: \*Immunohistochemical evaluation not required for patients with pancreatic cancer
* Measurable or evaluable disease
* No clinically significant pericardial effusion
* No known CNS or spinal cord involvement by tumor

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* At least 12 weeks

Hematopoietic

* Absolute neutrophil count at least 1,500/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

  * Seropositive allowed if clinically asymptomatic
* except if clinically asymptomatic and bilirubin and AST and ALT meet the outlined criteria

Renal

* Creatinine no greater than ULN
* Calcium no greater than ULN

Cardiovascular

* No New York Heart Association class II-IV cardiovascular disease

Pulmonary

* Oxygen saturation at least 93% on room air
* DLCO at least 50% of predicted\*
* Total lung capacity and vital capacity at least 50% of predicted\*
* FEV\_1 at least 50% of predicted\* NOTE: \*For patients with pleural mesothelioma and as clinically indicated

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No infection requiring parenteral antibiotics
* No HIV infection
* Serum neutralizing activity to SS1(dsFv)-PE38 immunotoxin (at 200 ng/mL) no greater than 75%

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 4 weeks since prior therapy and recovered
* No other concurrent antitumor therapy

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jul 1, 2003
Primary completion: —
Completion: —
First posted: Aug 7, 2003
Last update posted: Apr 30, 2015
Lead sponsor: National Cancer Institute (NCI) NIH
Keywords: ovarian carcinosarcoma, ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian mixed epithelial carcinoma, ovarian serous cystadenocarcinoma, ovarian undifferentiated adenocarcinoma, recurrent ovarian epithelial cancer, Brenner tumor, primary peritoneal cavity cancer, fallopian tube cancer, epithelial mesothelioma, recurrent malignant mesothelioma, recurrent pancreatic cancer, cervical squamous cell carcinoma, recurrent cervical cancer, recurrent non-small cell lung cancer, squamous cell lung cancer, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent metastatic squamous neck cancer with occult primary, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the nasopharynx

Data updated 22 days agoSource updated Apr 30, 2015source: clinicaltrials

Locations

Locations by country (2)

Country