| Source of record | National Research Register |
| Serial number at source | N0258073154 |
| Project title | A Phase II study to determine the biological effects of bispecific antibody MDX-H210 (520C9XH22) combined with GM-CSF in patients with advanced prostate cancer or renal cell carcinomas that express HER2/neu. |
| Current status of trial | Complete |
| Main research question | To obtain a preliminary assessment of therapeutic benefit as measured by anti-tumour effects and/or improvement in quality of life by MDX-H210 combined with GM-CSF in prostate cancer and renal cell carcinoma patients. |
| Design/methodology | Uncontrolled intervention (Phase 2) |
| Sample group description | RM 0/12, MC 0/30 |
| Multi-centre trial? | This is not a multi-centre trial. |
| Outcome measure | Tumour response, assessment of toxicity using NCI criteria, assessment of immunological response to therapy by measurement of cytokine plasma levels and anit-bispecific antibody activity. |
| Start date | 09/17/1997 |
| End date | 09/17/1997 |
| Primary keywords | ANTINEOPLASTIC-AGENTS-COMBINED Q-therapeutic-use; PROSTATIC-NEOPLASMS Q-drug-therapy; KIDNEY-NEOPLASMS Q-drug-therapy |
| Secondary keywords | HUMAN; RANDOMIZED-CONTROLLED-TRIAL; CLINICAL-TRIAL; GRANULOCYTE-MACROPHAGE-COLONY-STIMULATING-FACTOR Q-administration-&-dosage; MDX-H210 Q-administration-&-dosage; MALE; CLINICAL-TRIAL-PHASE-II |
| Region | London Regional Office |
| NRR Data Provider | The Royal Marsden NHS Trust |
| Funding organisation: name 1 | Bob Champion Cancer Trust |
| Funding reference number 1 | U/K |
| Contact name(s) | Dr David Dearnaley |
| Contact details | Radiotherapy Section
The Institute of Cancer Research
15 Cotswold Road
Sutton
Surrey
SM2 5NG
England
Tel: 020 8643 8901
Fax: 020 7808 2048
Email: davidd@icr.ac.uk |
| Further information | This record was taken from the National Research Register 2003, Issue 1, published in February 2003. Further information about this trial can be obtained from the lead researcher named above. |
| Date live in mRCT | 6 February 2003 |
