Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by:
Antisoma Research
ClinicalTrials.gov Identifier:
NCT00625768
First received: February 20, 2008
Last updated: August 24, 2009
Last verified: August 2009
  Purpose

To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Metastatic Malignant Melanoma
Drug: AS1409
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Antisoma Research:

Primary Outcome Measures:
  • Tumor assessment [ Time Frame: 6 weeks, response confirmed at 4 weeks ] [ Designated as safety issue: No ]
  • Biomarkers (interferon-γ and IP-10 Interferon) [ Time Frame: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose ] [ Designated as safety issue: No ]
  • Adverse event monitoring [ Time Frame: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AS1409
    Study drug
    Other Name: huBC1-huIL-12
Detailed Description:
  • To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose (MTD) of AS1409 in single and repeated doses.
  • To determine biological responses to AS1409, including interferon-γ and IP-10 circulating concentrations.
  • To determine preliminary pharmacokinetics of AS1409.
  • To determine the immunogenicity of AS1409
  • To explore the anti-tumour activity of AS1409.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 18 years or older at the time of giving informed consent.
  • Histologically confirmed diagnosis of renal cell carcinoma or malignant melanoma.
  • If renal cell carcinoma, of clear cell or chromophilic/papillary type, with metastases at any site (but excluding patients with single bony lesion only).
  • If malignant melanoma, unresectable Stage III disease or Stage IV disease, with metastases at any site (but excluding patients with single bony lesion only)
  • Patients with clinically stable CNS metastases may enter who have been treated with surgery or radiation and who do not require steroid therapy.
  • ECOG performance status 0-2.
  • Patients who have received prior systemic treatment for their malignancy with chemotherapeutic or biological therapies may enter, provided treatment was completed within 4 weeks of study entry.
  • Patients who have received prior experimental therapy may enter, provided treatment was completed within 12 weeks of study entry.
  • Have adequate bone marrow function as evidenced by neutrophils >1.5 x109/L and platelets >100 x109/L.
  • Have adequate liver and kidney function, as shown by serum bilirubin ≤1.5x upper limit of normal for the laboratory; ALT and AST both ≤2x upper limit of normal; and creatinine ≤1.5x upper limit of normal.
  • Have either evaluable or measurable disease (patients entering an ascending dosage cohort) or measurable disease (patients entering the study after MTD is defined).
  • Patients who have failed and or are ineligible for standard first line therapy (in accordance with individual institutional practice)

Exclusion Criteria:

Patients with any of the following will be excluded from the study:

  • Patients at poor medical risk because of non-malignant systemic disease or active infection.
  • History of clinically significant autoimmune or predominantly Th1-driven clinical disorders (such as rheumatoid arthritis, psoriasis, chronic inflammatory bowel disease, for example), with the exception of autoimmune endocrinopathies now treated with replacement therapy.
  • Diabetic retinopathy.
  • Substantive surgery within 4 weeks prior to study entry, or expectation of surgery during the study period.
  • Malignancy other than renal cell carcinoma or malignant melanoma within 5 years of study entry, except for non-melanoma skin cancer and cervical intraepithelial neoplasia treated definitively or other cancer from which the patient has been disease-free for 5 years.
  • Concurrent treatment with systemic steroids or with other immunosuppressive therapies.
  • If female, pregnant or breastfeeding;
  • Women of child bearing potential or sexually active males, unless (1) the patient (if female, or the patient's partner, if male) is surgically sterile or (2) using adequate contraception (defined as either IUD, oral or depot contraceptive, or barrier plus spermicide) while receiving study treatment and for at least 6 months after termination of treatment. Women must be post-menopausal for at least 2 years to be considered of non-childbearing potential
  • Any concurrent medical or psychological condition that would limit the ability of the patient to provide informed consent or to comply with the obligations of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625768

Locations
New Zealand
Auckland Medical School
Auckland, New Zealand
Waikato DHB
Hamilton, New Zealand
United Kingdom
Guys Hospital
London, United Kingdom, SE1 9RT
Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Antisoma Research
Investigators
Principal Investigator: James Spicer, MD Kings College School of Medicine
  More Information

Additional Information:
No publications provided by Antisoma Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chris Elston, Communications Manager, Antisoma Research
ClinicalTrials.gov Identifier: NCT00625768     History of Changes
Other Study ID Numbers: AS1409-101
Study First Received: February 20, 2008
Last Updated: August 24, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Antisoma Research:
Antibody
safety
tolerability
efficacy
metastatic renal cell carcinoma
metastatic malignant melanoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Melanoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 24, 2014