Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107198
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-11
First Post:
2005-04-05
Brief Title:
Treating Young Patients With Newly Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease LPHD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial is studying how well surgery andor combination chemotherapy with or without radiation therapy or observation only work in treating young patients with newly diagnosed stage I or stage II lymphocyte predominant Hodgkin disease LPHD Surgery may be an effective treatment for LPHD Drugs used in chemotherapy such as doxorubicin vincristine prednisone and cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill cancer cells Giving more than one drug combination chemotherapy with or without radiation therapy may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To preserve the excellent cure rate in patients with lymphocyte predominant Hodgkin disease LPHD while employing a treatment strategy that minimizes the exposure to chemotherapy and radiation therapy in appropriate patients
II To estimate the proportion of stage I patients with a single involved lymph node that is totally resected who can be cured with surgery alone
III To estimate the proportions of stage I unresected stage I resected whose disease has recurred after observation and stage II LPHD patients who can be cured with adriamycin doxorubicinvincristineprednisonecyclophosphamide AV-PC x 3 with involved field radiation therapy IFRT for those who are not in a CR after chemotherapy
IV To reduce the potential for long-term toxicity of LPHD treatment
OUTLINE This is a pilot study
Patients with stage IA disease who underwent confirmed complete resection of a single involved lymph node at diagnosis undergo observation only
Patients with stage IA disease who underwent possible complete resection of a single involved lymph node at diagnosis undergo imaging at 6-7 weeks after surgery Patients with a confirmed complete resection by imaging undergo observation only Patients who do not demonstrate complete resection by imaging proceed to combination chemotherapy with or without radiotherapy
Patients with stage IA disease who underwent a fine needle aspiration of a single involved lymph node OR an incomplete resection of a single involved lymph node at diagnosis may undergo a second surgery to achieve complete resection Patients who undergo complete resection during the second surgery undergo imaging at 6-7 weeks after surgery Patients with a confirmed complete resection by imaging undergo observation only Patients who do not undergo a second surgery OR do not achieve complete resection with the second surgery proceed to combination chemotherapy with or without radiotherapy Patients with stage IA disease with involvement of more than 1 lymph node OR stage IIA disease proceed directly to combination chemotherapy with or without radiotherapy
NOTE Patients with recurrent disease after observation only undergo biopsy and restaging and then proceed to combination chemotherapy with or without radiotherapy AS OF AMENDMENT 4 THE TREATMENT ARM FOR PATIENTS WHOSE CANCER RECURRED AFTER OBSERVATION ALONE IS NOW CLOSED
COMBINATION CHEMOTHERAPY Patients receive doxorubicin hydrochloride intravenously IV over 10-30 minutes and cyclophosphamide IV over 1 hour on day 1 vincristine IV over 1 minute on days 1 and 8 and prednisone orally PO or IV two or three times daily on days 1-7 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR after 3 courses of therapy proceed to follow-up Patients who do not achieve a CR proceed to involved-field radiotherapy
INVOLVED-FIELD RADIOTHERAPY IFRT Beginning within 3 weeks after completion of combination chemotherapy patients undergo IFRT once daily 5 days a week for 28 weeks 14 treatments
Patients are followed every 3 months for 2 years every 6 months for 3 years annually for 5 years and then every 5 years for 10 years
I To preserve the excellent cure rate in patients with lymphocyte predominant Hodgkin disease LPHD while employing a treatment strategy that minimizes the exposure to chemotherapy and radiation therapy in appropriate patients
II To estimate the proportion of stage I patients with a single involved lymph node that is totally resected who can be cured with surgery alone
III To estimate the proportions of stage I unresected stage I resected whose disease has recurred after observation and stage II LPHD patients who can be cured with adriamycin doxorubicinvincristineprednisonecyclophosphamide AV-PC x 3 with involved field radiation therapy IFRT for those who are not in a CR after chemotherapy
IV To reduce the potential for long-term toxicity of LPHD treatment
OUTLINE This is a pilot study
Patients with stage IA disease who underwent confirmed complete resection of a single involved lymph node at diagnosis undergo observation only
Patients with stage IA disease who underwent possible complete resection of a single involved lymph node at diagnosis undergo imaging at 6-7 weeks after surgery Patients with a confirmed complete resection by imaging undergo observation only Patients who do not demonstrate complete resection by imaging proceed to combination chemotherapy with or without radiotherapy
Patients with stage IA disease who underwent a fine needle aspiration of a single involved lymph node OR an incomplete resection of a single involved lymph node at diagnosis may undergo a second surgery to achieve complete resection Patients who undergo complete resection during the second surgery undergo imaging at 6-7 weeks after surgery Patients with a confirmed complete resection by imaging undergo observation only Patients who do not undergo a second surgery OR do not achieve complete resection with the second surgery proceed to combination chemotherapy with or without radiotherapy Patients with stage IA disease with involvement of more than 1 lymph node OR stage IIA disease proceed directly to combination chemotherapy with or without radiotherapy
NOTE Patients with recurrent disease after observation only undergo biopsy and restaging and then proceed to combination chemotherapy with or without radiotherapy AS OF AMENDMENT 4 THE TREATMENT ARM FOR PATIENTS WHOSE CANCER RECURRED AFTER OBSERVATION ALONE IS NOW CLOSED
COMBINATION CHEMOTHERAPY Patients receive doxorubicin hydrochloride intravenously IV over 10-30 minutes and cyclophosphamide IV over 1 hour on day 1 vincristine IV over 1 minute on days 1 and 8 and prednisone orally PO or IV two or three times daily on days 1-7 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR after 3 courses of therapy proceed to follow-up Patients who do not achieve a CR proceed to involved-field radiotherapy
INVOLVED-FIELD RADIOTHERAPY IFRT Beginning within 3 weeks after completion of combination chemotherapy patients undergo IFRT once daily 5 days a week for 28 weeks 14 treatments
Patients are followed every 3 months for 2 years every 6 months for 3 years annually for 5 years and then every 5 years for 10 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2009-00376 | REGISTRY | None | None |
| AHOD03P1 | None | None | None |
| CDR0000419921 | None | None | None |
| COG-AHOD03P1 | None | None | None |
| AHOD03P1 | OTHER | None | None |
| AHOD03P1 | OTHER | None | None |