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A Phase I Multicenter, Open Label, Clinical Trial of Immune Response, Safety and Tolerability of DNA Vector pPRA-PSM With Synthetic Peptides E-PRA and E-PSM in Subjects With Advance Solid Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Ovarian, Melanoma, Renal, Prostate, Colorectal, Endometrial Carcinoma, Cervical Carcinoma, Testicular Cancer, Thyroid Cancer, Small Cell Lung Carcinoma, Mesothelioma, Breast Carcinoma, Esophageal Carcinoma, Gastric Cancer, Pancreatic Carcinoma, Neuroendocrine Cancer, Liver Cancer, Gallbladder Cancer, Biliary Tract Cancer, Anal Carcinoma, Bone Sarcomas, Soft Tissue Sarcomas, Carcinoma of Unknown Origin, Primary

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Trial Information

A Phase I Multicenter, Open Label, Clinical Trial of Immune Response, Safety and Tolerability of DNA Vector pPRA-PSM With Synthetic Peptides E-PRA and E-PSM in Subjects With Advance Solid Malignancies


The majority of tumors are ignored by the immune system and it was thought for a long time
that tumor antigens did not exist. However, recently a number of tumor antigens have been
described. These antigens reside on cancer cells and can be recognized by specific T-cells
which can ultimately attack and destroy the tumor.


Inclusion Criteria:



18 years of age or older Advanced, refractory solid malignancy that is histologically
proven Measurable disease ECOG performance status of 0, 1 or 2 Adequate bone marrow
reserve as evidenced by a Absolute neutrophil count (ANC) = 1,500/microL; Platelet count =
100,000/microL Adequate renal and hepatic function as evidenced by a serum creatinine =
1.5 mg/dL; Serum total bilirubin = 2.0 mg/dL; Alkaline phosphatase = 3X the ULN for the
reference lab (= 5 the ULN for the reference lab for subjects with known hepatic
metastases); SGOT/SGPT = 3X the ULN for the reference lab (= 5 the ULN for the reference
lab for subjects with known hepatic metastases)

Exclusion Criteria:

Symptomatic central nervous system (CNS) metastases Any autoimmune disorder Positive HIV,
hepatitis B or hepatitis C antibody test Any allogeneic transplant Congestive heart
failure Affected inguinal lymph nodes (metastatic process) or lack inguinal lymph nodes
(resection)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the immunologic response to the treatment with MKC1106-PP regimen and 2) to determine the safety and adverse event profile of MKC1106-PP

Outcome Time Frame:

Every 6 Weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MKC1106-PP-001

NCT ID:

NCT00423254

Start Date:

February 2007

Completion Date:

November 2009

Related Keywords:

  • Ovarian
  • Melanoma
  • Renal
  • Prostate
  • Colorectal
  • Endometrial Carcinoma
  • Cervical Carcinoma
  • Testicular Cancer
  • Thyroid Cancer
  • Small Cell Lung Carcinoma
  • Mesothelioma
  • Breast Carcinoma
  • Esophageal Carcinoma
  • Gastric Cancer
  • Pancreatic Carcinoma
  • Neuroendocrine Cancer
  • Liver Cancer
  • Gallbladder Cancer
  • Biliary Tract Cancer
  • Anal Carcinoma
  • Bone Sarcomas
  • Soft Tissue Sarcomas
  • Carcinoma of Unknown Origin, Primary
  • Cancer Vaccine
  • Anus Neoplasms
  • Breast Neoplasms
  • Carcinoma
  • Thyroid Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Liver Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Melanoma
  • Mesothelioma
  • Osteosarcoma
  • Pancreatic Neoplasms
  • Testicular Neoplasms
  • Small Cell Lung Carcinoma
  • Gallbladder Neoplasms
  • Adenoma
  • Uterine Cervical Neoplasms
  • Endometrial Neoplasms
  • Biliary Tract Neoplasms
  • Sarcoma

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
Nevada Cancer InstituteLas Vegas, Nevada  89135
Lombardi Comprehensive Cancer Center at GeorgetownWashington, District of Columbia  20057
H Lee Moffitt Cancer Center University of So FloridaTampa, Florida  33612