SNPMiner Trials by Shray Alag

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Report for Mutation R572Y

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 3 clinical trials

Clinical Trials

1 Phase I/II Combination Immunotherapy After ASCT for Advanced Myeloma to Study HTERT Vaccination Followed by Adoptive Transfer of Vaccine-Primed Autologous T Cells

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. A stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Giving an infusion of the donor's T cells after the transplant may help destroy any remaining cancer cells. PURPOSE: This phase I/II trial is studying the side effects of stem cell transplant given together with chemotherapy and biological therapy and to see how well it works in treating patients with high-risk or refractory multiple myeloma.

NCT00499577 Multiple Myeloma and Plasma Cell Neoplasm Biological: CMV pp65 peptide Biological: hTERT I540/R572Y/D988Y multipeptide vaccine Biological: pneumococcal polyvalent vaccine Biological: survivin Sur1M2 peptide vaccine
MeSH:Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma
HPO:Multiple myeloma Plasmacytoma

- Immunization 1: - Group 1 (HLA-A2 positive): Patients receive the following peptides emulsified in incomplete Freund's adjuvant VG: I) hTERT I540 peptide; ii) hTERT R572Y peptide; iii) hTERT D988Y peptide; iv) survivin Sur1M2 peptide ; and v) CMV control peptide N495 subcutaneously (SC). --- R572Y ---

Primary Outcomes

Measure: Toxicity at 21 and 28 days post-transplant

Measure: T-cell responses against the hTERT vaccine as measured by tetramer assays at 100 days post-transplant

Measure: Paraprotein levels in the blood or urine and serum free light chain analyses at 60 days and at 6 months post-transplant

Secondary Outcomes

Measure: Cytotoxic T-cell responses against autologous myeloma cell at day 100 post-transplant via chromium-51 release or flow-based assays

Measure: Maximum clinical response

Measure: 1 and 2-year event-free survival

Measure: Overall survival rates

Measure: CD4 and CD8 T-cell responses against cytomegalovirus (CMV) at days 60 and 100 post-transplantation by CFSE dye dilution assays

Measure: Composite binding antibody responses at days 60 and day 100 post-transplant by ELISA

2 A Study of hTERT/Survivin Multi-peptide Vaccine With Daclizumab and Prevnar for Patients With Metastatic Breast Cancer

This is a study on how to activate the immune system with a vaccine. The vaccine is made up of two proteins found in breast cancer: telomerase and survivin. The vaccine is given in combination with other drugs that may also have an effect on the immune system and attack the cancer. The goals of the study are: 1. to test the safety of the combination of agents 2. to find out what effects the treatment has on advanced breast cancer

NCT00573495 Breast Neoplasm Breast Cancer Cancer of the Breast Carcinoma, Ductal Biological: hTERT/Survivin Multi-Peptide Vaccine
MeSH:Breast Neoplasms Carcinoma, Ductal
HPO:Breast carcinoma Neoplasm of the breast

The two "heteroclitic" peptides are R572Y (YLFFYRKSV) and D988Y (YLQVNSLQTV), which bind HLA-A2 with high avidity and elicit specific CTL (cytotoxic T lymphocyte) responses using healthy donor mononuclear cells in vitro. --- R572Y ---

Primary Outcomes

Measure: Safety

Time: Up to 30 days after the last vaccination

Secondary Outcomes

Measure: Immunologic response

Time: After 4th vaccination, then after every 3-4 vaccinations, and then every 6 months

3 Phase I/II Combination Immunotherapy After ASCT for Advanced Myeloma to Study HTERT Vaccination Followed by Adoptive Transfer of Vaccine-Primed Autologous T Cells

The purpose of this study is: 1. To evaluate the safety of activated T cell infusions and immunization with hTERT multi-peptide vaccine in the post-transplant setting and whether the combination can delay hematopoietic recovery or induce other autoimmune events. 2. To determine whether the strategy of infusing vaccine-primed T-cells early after transplant in conjunction with post-transplant boosters leads to the induction of cellular immune responses to hTERT.

NCT00834665 Multiple Myeloma Biological: hTERT vaccine, GM-CSF, PCV, T cell infusion Biological: GM-CSF, PCV, T cell infusion
MeSH:Multiple Myeloma Neoplasms, Plasma Cell
HPO:Multiple myeloma

The two investigational products to be evaluated in this Phase I/II study include: 1. hTERT Vaccine (the putative tumor vaccine)- a multi-peptide vaccine consisting of 3 peptides against the catalytic subunit of telomerase (hTERT D988Y, I540, and R572Y), 1 survivin peptide (Sur1M2- an antiapoptotic protein), and 1 CMV (cytopeptide (N495). --- D988Y --- --- R572Y ---

Primary Outcomes

Description: Incidence of delayed hematopoietic recovery and the incidence of Grade 3 or greater autoimmune events

Measure: Primary toxicity endpoint

Time: 2 yrs

HPO Nodes