Considering that UCLA would need an IND number before they apply for their Phase I grant, and that Phase I grant was received in April 2001, I think sometime in 2000 is a safe assumption for the first IND 8434. And then, well, one would go forward from the first grant if they were being objective about it. So sometime after April 2001 for IND 10206 and IND 11053. But, we also know that Phase I grant ran until 2002, based on the grant timeline below. Phase I preliminary findings are needed before steam-rolling ahead to apply for the next phase II or grant (received IND grant in 2006). That would put the timeline into 2002; and given there's quite a span of # between 8434 and 10206, a two year lag accounts for the skip of the 9000s. In thinking through further, the received their NCT in Sept 2002. It takes 30 days to receive an NCT after receipt of an IND, so I'm suggesting around July -August 2002 to receive the IND #10206 seems about right. But, you can research Clinicaltrial.gov if you want to explore the process timeline further.
Project Number: 1R21CA091545-01 Contact PI / Project Leader: LIAU, LINDA M Title: PHASE I STUDY OF DENDRITIC CELL IMMUNOTHERAPY Awardee Organization: UNIVERSITY OF CALIFORNIA LOS ANGELES Contact PI / Project Leader Information: Program Official Information:
Name: LIAU, LINDA M Title: PROFESSOR Name: WU, ROY S.
Organization: Department/ Organization Type: Congressional District: Name: UNIVERSITY OF CALIFORNIA LOS ANGELES City: LOS ANGELES Country: UNITED STATES (US) SURGERY SCHOOLS OF MEDICINE State Code: CA District: 30 Other Information: FOA: PA-00-047 Study Section: Special Emphasis Panel [ZRG1-CONC (01)] Fiscal Year: 2001 Award Notice Date: 9-APR-2001 DUNS Number: 092530369 Project Start Date: 1-JUL-2001 Budget Start Date: 1-JUL-2001 CFDA Code: 395 Project End Date: 30-JUN-2003 Budget End Date: 30-JUN-2002 Administering Institutes or Centers: NATIONAL CANCER INSTITUTE Project Funding Information for 2001: Total Funding: $321,300
Project Number: 1R21CA091545-01 Contact PI / Project Leader: LIAU, LINDA M Title: PHASE I STUDY OF DENDRITIC CELL IMMUNOTHERAPY Awardee Organization: UNIVERSITY OF CALIFORNIA LOS ANGELES
Total project funding amount for 3 projects is $697,518*
* Only NIH,CDC,and FDA funding data. Page 1 of 1 Project Number Sub # Project Title Contact PI / Project Leader Organization FY Admin IC FY Total Costby IC
5R21CA091545-02 PHASE I STUDY OF DENDRITIC CELL IMMUNOTHERAPY LIAU, LINDA M UNIVERSITY OF CALIFORNIA LOS ANGELES 2002 NCI $320,250
3R21CA091545-02S1 PHASE I STUDY OF DENDRITIC CELL IMMUNOTHERAPY LIAU, LINDA M UNIVERSITY OF CALIFORNIA LOS ANGELES 2002 NCI $55,968
1R21CA091545-01 PHASE I STUDY OF DENDRITIC CELL IMMUNOTHERAPY LIAU, LINDA M UNIVERSITY OF CALIFORNIA LOS ANGELES 2001 NCI $321,300
PHASE I STUDY OF DENDRITIC CELL IMMUNOTHERAPY
Abstract Text: DESCRIPTION (provided by applicant): Malignant gliomas (anaplastic astrocytoma and glioblastoma multiforme) are the most frequent primary brain tumors in adults and account for about 2 percent of all cancers. It is currently incurable, inevitably fatal, and inflicts an enormous social and economic impact, often striking patients during the prime of their lives. This sobering fact underscores the need to rethink standard approaches to treating brain cancer and to base therapeutic strategies on advances in our understanding of basic cancer biology and tumor immunology. Although a recent renaissance in cancer vaccine research has produced a plethora of approaches designed to elicit immune responses against extra-cranial tumors, there is a paucity of rigorous clinical evaluations of immunotherapeutic treatments for intra-cranial brain tumors. This is due primarily to gaps in our existing knowledge of the unique immunological milieu of the central nervous system (CNS), which have limited conclusive hypotheses about whether brain tumor immunotherapy is actually feasible, safe, or clinically relevant. Therefore, the broad, long-term objectives of this research are: i) to develop and optimize immunotherapy approaches for the clinical treatment of intracranial brain tumors; and ii) to gain a better understanding of the anti-tumor immune responses generated within the traditionally "immune privileged" CNS. In order to achieve these objectives, this project initiates a Phase I study of dendritic cell (DC) immunotherapy for patients with malignant gliomas. Dendritic cells, antigen-presenting cells specialized to elicit cellular immunity, have been used in pilot clinical trials for patients with non-CNS cancers. The specific aims of our project are: 1) to determine the feasibility, safety and toxicity of intradermal injections of autologous peptide-pulsed dendritic cells in patients with CNS gliomas; 2) to monitor tumor progression and cellular/humoral immune responses in brain tumor patients injected with antigen-pulsed dendritic cells and compare them with those of historical controls; and 3) to evaluate the nature of immune infiltrates and cytokine profiles in brain tumor specimens prior to treatment (at initial surgical resection) and following DC vaccination (at subsequent surgical resection for recurrence or autopsy). Correlation of the clinical and immunological response data in these patients will hopefully validate mechanistic hypotheses that systemic immune responses can translate to relevant immune responses within the CNS, which in turn may result in clinical benefit for brain tumor patients. The results of this research will help to determine the pertinent clinical and immunological endpoint measures that can meaningfully guide further clinical development of brain tumor immunotherapies.
Title (Link to full-text in PubMed Central) Journal (Link to PubMed abstract) Authors
Dendritic cell vaccines for brain tumors. Neurosurgery
clinics of North America. 2010 Jan; 21 (1) :139-57 Kim, Won; Liau, Linda M Dendritic cell vaccination in glioblastoma patients induces systemic and intracranial T-cell responses modulated by the local central nervous system tumor microenvironment. Clinical cancer research : an official journal of the American Association for Cancer Research.. 2005 Aug 1; 11 (15) :5515-25 Liau, Linda M; Prins, Robert M; Kiertscher, Sylvia M; Odesa, Sylvia K; Kremen, Thomas J; Giovannone, Adrian J; Lin, Jia-Wei; Chute, Dennis J; Mischel, Paul S; Cloughesy, Timothy F; Roth, Michael D
Cellular immunity and immunotherapy of brain tumors. Frontiers in bioscience : a journal and virtual library.. 2004 Sep 1; 9 :3124-36 Prins, Robert M; Liau, Linda M Modulation of major histocompatibility complex Class I molecules and major histocompatibility complex-bound immunogenic peptides induced by interferon-alpha and interferon-gamma treatment of human glioblastoma multiforme. Journal of neurosurgery. . 2004 Feb; 100 (2) :310-9 Yang, Isaac; Kremen, Thomas J; Giovannone, Adrian J; Paik, Elena; Odesa, Sylvia K; Prins, Robert M; Liau, Linda M
Immunotherapeutic targeting of shared melanoma-associated antigens in a murine glioma model. Cancer research. 2003 Dec 1; 63 (23) :8487-91 Prins, Robert M; Odesa, Sylvia K; Liau, Linda M Immunology and immunotherapy in neurosurgical disease. Neurosurgery. 2003 Jul; 53 (1) :144-52; discussion 152-3 Prins, Robert M; Liau, Linda M
http://clincancerres.aacrjournals.org/content/11/15/5515.long Cellular immunity and immunotherapy of brain tumors. — Liau, Linda M; Prins, Robert M; Kiertscher, Sylvia M; Odesa, Sylvia K; Kremen, Thomas J; Giovannone, Adrian J; Lin, Jia-Wei; Chute, Dennis J; Mischel, Paul S; Cloughesy, Timothy F; Roth, Michael D
http://www.ncbi.nlm.nih.gov/pubmed/15086239 Modulation of major histocompatibility complex Class I molecules and major histocompatibility complex-bound immunogenic peptides induced by interferon-alpha and interferon-gamma treatment of human glioblastoma multiforme. — Yang, Isaac; Kremen, Thomas J; Giovannone, Adrian J; Paik, Elena; Odesa, Sylvia K; Prins, Robert M; Liau, Linda M
